Approved IDE Studies

The following IDE studies have met CMS’ standards for coverage. Studies with the Category A are approved for coverage of routine services only. Studies with the Category B are approved for coverage of the Category B device and related services, and routine services.

Study Title	Sponsor Name	NCT Number	IDE Number	CMS Approval Date	Category
Study Title Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease	Sponsor Name R3 Vascular Inc.	NCT Number NCT06071429	IDE Number G230339	CMS Approval Date 2024-11-13	Category B
Study Title BIOTRONIK Conduction System Pacing with the Solia Lead	Sponsor Name Biotronik, Inc.	NCT Number NCT06540079	IDE Number G210349	CMS Approval Date 2024-11-13	Category B
Study Title A Multicenter, Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System (80cm) When Used in Conjunction With the FDA-cleared ENROUTE Transcarotid Neuroprotection System (NPS) in Patients at High Ris...	Sponsor Name InspireMD	NCT Number NCT06653387	IDE Number G240166	CMS Approval Date 2024-11-13	Category B
Study Title STEP: StrokeNet Thrombectomy Endovascular Platform	Sponsor Name Medical University of South Carolina	NCT Number NCT06289985	IDE Number G200273	CMS Approval Date 2024-11-12	Category B
Study Title Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II	Sponsor Name Neptune Medical	NCT Number NCT06576427	IDE Number G240089	CMS Approval Date 2024-11-12	Category B
Study Title The MAGICAL SV Trial - a Prospective, Multicenter, Randomized, Two-Arm, Single-blind Non Inferiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus-Coated Balloon in the Treatment of Small Vessels in Patients with Coronary Artery...	Sponsor Name Concept Medical Inc.	NCT Number NCT06271590	IDE Number G230087	CMS Approval Date 2024-11-12	Category B
Study Title A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair (NeuroSpan-1)	Sponsor Name Auxilium Biotechnologies	NCT Number NCT06529835	IDE Number G240142	CMS Approval Date 2024-11-05	Category B
Study Title A Clinical Investigation Evaluating Safety and Effectiveness of Primary Hybrid Construct of Mobi-C and ACDF in the Treatment of Two-level Symptomatic Degenerative Disc Disease in the Cervical Spine.	Sponsor Name ZimVie	NCT Number NCT06485206	IDE Number G230217	CMS Approval Date 2024-11-04	Category B
Study Title Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms	Sponsor Name Bjoern D. Suckow	NCT Number NCT06501872	IDE Number G240122	CMS Approval Date 2024-11-04	Category B
Study Title Early Feasibility Study of the Supira System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (HRPCI) - The SUPPORT I Trial	Sponsor Name Supira Medical	NCT Number NCT06087575	IDE Number G230317	CMS Approval Date 2024-11-04	Category B
Study Title Evaluation of a Simple Neuroprosthesis for Restoration of Hand Function in Cervical Spinal Cord Injury	Sponsor Name MetroHealth Medical Center	NCT Number NCT06611748	IDE Number G240096	CMS Approval Date 2024-11-04	Category B
Study Title Chronic Subdural Hematoma Treatment with Embolization Versus Surgery Study (CHESS)	Sponsor Name The University of Texas Medical Branch, Galveston	NCT Number NCT06347796	IDE Number G210031	CMS Approval Date 2024-10-24	Category B
Study Title A Clinical Study of the InQB8 Transcatheter Tricuspid Valve Replacement System	Sponsor Name inQB8 Medical Technologies, LLC	NCT Number NCT06611579	IDE Number G240117	CMS Approval Date 2024-10-15	Category B
Study Title PICANTE: PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm	Sponsor Name Kardion Inc	NCT Number NCT06445608	IDE Number G230284	CMS Approval Date 2024-10-11	Category B
Study Title OsteoAdapt SP Advanced Bone Graft	Sponsor Name Theradaptive, Inc.	NCT Number NCT06154005	IDE Number G230350	CMS Approval Date 2024-10-11	Category B
Study Title Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)	Sponsor Name CardioMech AS	NCT Number NCT04820764	IDE Number G210046	CMS Approval Date 2024-10-11	Category A
Study Title TRIal to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System in Patients With Severe or Greater Tricuspid Regurgitation - SafetY and Clinical Performance	Sponsor Name Jenscare Innovation Inc.	NCT Number NCT06568003	IDE Number G240058	CMS Approval Date 2024-10-09	Category B
Study Title Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure	Sponsor Name Abbott Medical Devices	NCT Number NCT06526195	IDE Number G240119	CMS Approval Date 2024-10-08	Category B
Study Title AGENT IDE: A Prospective, Randomized (2:1), Multicenter Trial to Assess the Safety and Effectiveness of the AgentTM Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)	Sponsor Name Boston Scientific Corporation	NCT Number NCT06492174	IDE Number G200100	CMS Approval Date 2024-09-26	Category B
Study Title An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema: The CONVERT II Trial	Sponsor Name Pulmonx Corporation	NCT Number NCT06035120	IDE Number G230321	CMS Approval Date 2024-09-25	Category A
Study Title A Prospective, Randomized, Dual-arm Multi-center Study to Assess the Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA5 Device in Combination With a Stent Retriever	Sponsor Name Anaconda Biomed S.L.	NCT Number NCT06370182	IDE Number G230342	CMS Approval Date 2024-09-24	Category B
Study Title RECOVER-HF - RandomizEd, Multi-Center, Double-Blinded Study of SynchrOnized Diaphragmatic Stimulation (SDS) for ImproVEment of Symptomatic Reduced Ejection Fraction Heart Failure	Sponsor Name VisCardia Inc.	NCT Number NCT06552637	IDE Number G220315	CMS Approval Date 2024-09-23	Category B
Study Title Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE™ Catheter	Sponsor Name Biosense Webster, Inc.	NCT Number NCT06455098	IDE Number G230315	CMS Approval Date 2024-09-23	Category B
Study Title Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels with Calcific Walls and Enhance Vascular Compliance and Remodeling for Peripheral Artery Disease	Sponsor Name Amplitude Vascular Systems, Inc.	NCT Number NCT06457685	IDE Number G240108	CMS Approval Date 2024-09-23	Category B
Study Title Prospective Multi-Center Randomized Controlled Trial to Evaluate the Safety and Efficacy of AcoArt Litos Paclitaxel Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Versus Non-Coated Standard Balloon Angioplasty for the Treatment of Infrapoplite...	Sponsor Name Acotec Scientific Co., Ltd	NCT Number NCT06330493	IDE Number G220025	CMS Approval Date 2024-09-16	Category B
Study Title An EFS to Evaluate the Safety and Preliminary Effectiveness of the CGuard Prime™ Carotid Stent Placement in the Procedure Setting of Acute Ischemic Stroke	Sponsor Name Jacobs institute	NCT Number NCT06447116	IDE Number G230344	CMS Approval Date 2024-09-16	Category B
Study Title AltaValve Pivotal Trial	Sponsor Name 4C Medical Technologies, Inc.	NCT Number NCT06465745	IDE Number G190128	CMS Approval Date 2024-09-12	Category B
Study Title First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease	Sponsor Name Medinol Ltd.	NCT Number NCT06410313	IDE Number G240071	CMS Approval Date 2024-09-10	Category B
Study Title Posterior Wall Substrate Modification Using Irreversible Electroporation for the Treatment of Paroxysmal Atrial Fibrillation	Sponsor Name Brigham and Women's Hospital	NCT Number NCT06364215	IDE Number G240116	CMS Approval Date 2024-09-10	Category B
Study Title A Prospective, Multi-Center, Single-Blind, Randomized, Active-Controlled- Study of BD ORC Original Absorbable Hemostat Compared with Surgicel® Original Absorbable Hemostat	Sponsor Name Becton, Dickinson and Company	NCT Number NCT05741463	IDE Number G220336	CMS Approval Date 2024-08-27	Category B
Study Title Automated Insulin Delivery for Inpatients With Dysglycemia (AIDING) Randomized Controlled Trial	Sponsor Name Emory University	NCT Number NCT06418880	IDE Number G240017	CMS Approval Date 2024-08-21	Category B
Study Title Chronic Evaluation of Novel Pacemaker System	Sponsor Name Calyan Technologies	NCT Number NCT06056817	IDE Number G220218	CMS Approval Date 2024-08-21	Category A
Study Title Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction With Infection Outcomes Assessment (ARIA)	Sponsor Name Melodi Health, Inc.	NCT Number NCT06027996	IDE Number G230106	CMS Approval Date 2024-08-16	Category B
Study Title A Prospective Randomized Controlled Trial of Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System	Sponsor Name Enterra Medical, Inc.	NCT Number NCT06464926	IDE Number G240099	CMS Approval Date 2024-08-07	Category B
Study Title Safety and Efficacy of Pulsed-field Ablation for Atrial Fibrillation in High Versus Low-volume Ablation Centers	Sponsor Name Texas Cardiac Arrhythmia Research Foundation	NCT Number NCT06488820	IDE Number G230341	CMS Approval Date 2024-08-07	Category B
Study Title The TRICURE EFS TRiCares Topaz Transfemoral TRICUspid Heart Valve REplacement System Early Feasibility Study	Sponsor Name TRiCares	NCT Number NCT06506942	IDE Number G230265	CMS Approval Date 2024-08-07	Category B
Study Title A randomized, assessor-masked, controlled, multi-center, non-inferiority comparison study to evaluate safety and effectiveness of the NuVisc PRO versus Amvisc® Plus in patients undergoing cataract surgery via the anterior chamber	Sponsor Name BVI	NCT Number NCT06463080	IDE Number G210332	CMS Approval Date 2024-08-02	Category B
Study Title A Prospective, Multicenter, Randomized, Controlled Clinical Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction	Sponsor Name Bausch & Lomb Incorporated	NCT Number NCT06333015	IDE Number G240026	CMS Approval Date 2024-08-02	Category B
Study Title RENEGADE: Radioembolization for Early Stage Renal Cell Carcinoma: An Open- Label, Prospective, Multi-Center, Phase 1/2 Safety Trial	Sponsor Name Jonsson Comprehensive Cancer Center	NCT Number NCT06432036	IDE Number G230182	CMS Approval Date 2024-07-31	Category B
Study Title MAGICAL BTK: Randomized Controlled Trial of MAGIcTouch - Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease	Sponsor Name Concept Medical Inc.	NCT Number NCT06182397	IDE Number G220307	CMS Approval Date 2024-07-31	Category B
Study Title Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation	Sponsor Name Javelin Medical	NCT Number NCT05723926	IDE Number G220272	CMS Approval Date 2024-07-30	Category B
Study Title Acute safety and device performance of the Sapphire 3 (⌀ 0.85, 1.0 and 1.25mm) coronary dilatation catheter in the predilatation of Chronic Total Occlusion (CTO) lesions	Sponsor Name OrbusNeich Medical	NCT Number NCT06358508	IDE Number G240001	CMS Approval Date 2024-07-30	Category B
Study Title Evaluation of a Simple-Prep Controlled Embolic (GPX Trial)	Sponsor Name Fluidx Medical Technology, Inc.	NCT Number NCT06453642	IDE Number G230312	CMS Approval Date 2024-07-24	Category B
Study Title SEAL™IT: Saccular Endovascular Aneurysm Lattice System Interventional Pivotal Trial	Sponsor Name Galaxy Therapeutics INC	NCT Number NCT05831202	IDE Number G230099	CMS Approval Date 2024-07-24	Category B
Study Title At Elana 841p	Sponsor Name Zeiss Group	NCT Number NCT06264232	IDE Number G230236	CMS Approval Date 2024-07-23	Category B
Study Title LUNAR-2: Pivotal, Randomized, Open-Label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab and Platinum-based Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer	Sponsor Name NovoCure GmbH	NCT Number NCT06216301	IDE Number G230153	CMS Approval Date 2024-07-23	Category B
Study Title A Prospective Multi-Center, Single-Arm Study of Endoscopic Ultrasound-Guided Gastroenterostomy With Lumen-Apposing Metal Stent for Gastric Outlet Obstruction From Malignant Unresectable Disease	Sponsor Name Boston Scientific Corporation	NCT Number NCT06174805	IDE Number G230195	CMS Approval Date 2024-07-22	Category B
Study Title Laser In Situ Fenestration for Endovascular Aortic Repair (LIFE) Study	Sponsor Name Jonathan Bath	NCT Number NCT06411990	IDE Number G240064	CMS Approval Date 2024-07-16	Category B
Study Title Acellular Dermal Matrix Investigation in Breast Reconstruction	Sponsor Name RTI Surgical	NCT Number NCT06456554	IDE Number G230299	CMS Approval Date 2024-07-09	Category B
Study Title A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients With Acute Kidney Injury Requiring Continuous Kidney Replacement Therapy	Sponsor Name SeaStar Medical	NCT Number NCT05758077	IDE Number BB29239	CMS Approval Date 2024-07-03	Category B
Study Title Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens	Sponsor Name Johnson & Johnson Surgical Vision, Inc.	NCT Number NCT06377514	IDE Number G240043	CMS Approval Date 2024-07-03	Category B
Study Title Request for Medicare Coverage of the BrioHealth Solutions Investigation of a Novel, magNetically levitated VAD for the treatment of refractOry left Ventricular heArT failurE (INNOVATE Trial)	Sponsor Name BrioHealth Solutions, Inc.	NCT Number NCT06310031	IDE Number G240020	CMS Approval Date 2024-06-21	Category B
Study Title The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy	Sponsor Name Avantec Vascular	NCT Number NCT06321575	IDE Number G230278	CMS Approval Date 2024-06-17	Category B
Study Title A Prospective, Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation - TRICAV Trial	Sponsor Name P+F Products + Features USA Inc.	NCT Number NCT06137807	IDE Number G240065	CMS Approval Date 2024-06-06	Category B
Study Title A Multi-Center, Prospective, Open-label, Randomized, Non-inferiority Study of 3M™ Topical Tissue Adhesive Versus Commercially Available Tissue Adhesive for the Closure of Traumatic Lacerations and Surgical Incisions	Sponsor Name 3M	NCT Number NCT06217081	IDE Number G230165	CMS Approval Date 2024-06-04	Category B
Study Title A Prospective, Multicenter Study to Evaluate the Safety and Efficacy of an Aspiration Thrombectomy System in Acute Pulmonary Embolism	Sponsor Name Argon Medical Devices	NCT Number NCT06189313	IDE Number G230251	CMS Approval Date 2024-06-04	Category B
Study Title VOLT-AF IDE Clinical Study	Sponsor Name Abbott Medical Devices	NCT Number NCT06223789	IDE Number G230353	CMS Approval Date 2024-05-28	Category B
Study Title VITALYST EFS: VITALYST Temporary Percutaneous Transvalvular Circulatory Support System Early Feasibility Study	Sponsor Name Boston Scientific Corporation	NCT Number NCT06132568	IDE Number G230288	CMS Approval Date 2024-05-22	Category B
Study Title Randomized, Prospective, Multi-Center Study of the INHANCE Stemless Total Reverse Shoulder System	Sponsor Name DePuy Orthopaedics	NCT Number NCT06323980	IDE Number G230185	CMS Approval Date 2024-05-22	Category B
Study Title Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel	Sponsor Name GIE Medical	NCT Number NCT05561127	IDE Number G220168	CMS Approval Date 2024-05-08	Category B
Study Title Electrophysiological Recordings from Deep Brain Stimulation Electrodes for Pain, EPR Pain	Sponsor Name St. Joseph's Hospital and Medical Center, Phoenix	NCT Number NCT06019793	IDE Number G230198	CMS Approval Date 2024-05-08	Category B
Study Title Prospective, Multicenter, Historical Control, Pivotal Study of the Aquedeon Medical Duett™ Vascular Graft System for Surgical Treatment of the Thoracic Aorta	Sponsor Name Aquedeon Medical, Inc.	NCT Number NCT06253143	IDE Number G230197	CMS Approval Date 2024-04-22	Category B
Study Title A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ Device (The ShortCut™ CAS)	Sponsor Name Pi-cardia	NCT Number NCT06211296	IDE Number G220165	CMS Approval Date 2024-04-18	Category B
Study Title Safety and Feasibility of Robotic Single-port (SP) Nipple Sparing Mastectomy: A Single Institution, Single Arm Pilot Trial	Sponsor Name Deborah Farr, MD	NCT Number NCT05245812	IDE Number G220001	CMS Approval Date 2024-04-16	Category B
Study Title A Phase II Study of Peri-Operative NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma	Sponsor Name Ashish Manne	NCT Number NCT05624918	IDE Number G220291	CMS Approval Date 2024-04-16	Category A
Study Title Pivotal Multicenter Trial of the Boomerang™ Catheter for Percutaneous Deep Vein Arterialization (pDVA)	Sponsor Name Aveera Medical, Inc.	NCT Number NCT06311773	IDE Number G240005	CMS Approval Date 2024-04-16	Category B
Study Title Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial	Sponsor Name Sonavex, Inc.	NCT Number NCT06190717	IDE Number G230252	CMS Approval Date 2024-04-11	Category B
Study Title Early Feasibility Study (EFS) to Assess the Safety and Performance of the Innoventric Trillium™ Stent Graft in the Treatment of Severe or Greater Tricuspid Regurgitation (TR)	Sponsor Name Innoventric LTD	NCT Number NCT06212193	IDE Number G230190	CMS Approval Date 2024-04-09	Category A
Study Title Efficacy of Lipiodol Embolization for Chronic Tendinopathy of the Rotator Cuff	Sponsor Name Brigham and Women's Hospital	NCT Number NCT06095050	IDE Number G230189	CMS Approval Date 2024-04-03	Category B
Study Title A Prospective, Single-arm, Multi-center, Open-label Trial Evaluating the Continuous Application of Prevena™ Therapy for up to 14 Days	Sponsor Name 3M	NCT Number NCT05614869	IDE Number G220009	CMS Approval Date 2024-04-02	Category B
Study Title A Randomized Clinical Study Evaluating the Safety of Regenn® Negative Pressure Therapy System in Orthopaedic Surgical Wound Management	Sponsor Name Progenerative Medical, Inc	NCT Number NCT06259409	IDE Number G230174	CMS Approval Date 2024-03-28	Category B
Study Title CorMatrix® Cor™ TRICUSPID ECM® Valve Replacement Study	Sponsor Name CorMatrix Cardiovascular, Inc.	NCT Number NCT05742906	IDE Number G180240	CMS Approval Date 2024-03-08	Category B
Study Title Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Ischemic Heart Failure II Trial	Sponsor Name BioCardia, Inc.	NCT Number NCT06258447	IDE Number BB16057	CMS Approval Date 2024-03-08	Category B
Study Title Evaluation of a Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions in Patients With Chronic Angina Refractory to Maximally Tolerated Guideline Directed Medical Therapy	Sponsor Name VasoStar, LLC	NCT Number NCT06193954	IDE Number G230202	CMS Approval Date 2024-03-08	Category B
Study Title BiVACOR® Total Artificial Heart Early Feasibility Study	Sponsor Name BiVACOR Inc.	NCT Number NCT06174103	IDE Number G230187	CMS Approval Date 2024-03-04	Category B
Study Title A Prospective Randomized Single-Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 PTCA Drug Eluting Balloon in the Treatment of Subjects With De Novo Coronary Lesions in Small Vessels	Sponsor Name M.A. Med Alliance S.A.	NCT Number NCT05946629	IDE Number G220321	CMS Approval Date 2024-03-04	Category B
Study Title Phase I Clinical Trial of Bcl2 Inhibitor Venetoclax in Combination With Lenalidomide and Dexamethasone (Ven-Rd), Daratumumab and Dexamethasone (Ven-Dd), or Daratumumab-Lenalidomide-Dexamethasone (Ven-DRd) in t(11;14) Multiple Myeloma	Sponsor Name Mayo Clinic	NCT Number NCT06042725	IDE Number G230104	CMS Approval Date 2024-02-22	Category B
Study Title A Single-center Pilot Study Using TCRα/β and CD45RA Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Cell Transplantation in Adults (HAPLO2022)	Sponsor Name Miltenyi Biomedicine GmbH	NCT Number NCT06225050	IDE Number BB28591	CMS Approval Date 2024-02-22	Category B
Study Title HANAROSTENT® Biliary Flap Lasso Stent System	Sponsor Name Olympus Corporation of the Americas	NCT Number NCT05058261	IDE Number G210097-1	CMS Approval Date 2024-02-22	Category B
Study Title Evaluation of the Safety and Performance of the Half Moon Transcatheter Mitral Valve Repair System in High Risk Patients With Severe, Symptomatic Mitral Regurgitation	Sponsor Name Half Moon Medical	NCT Number NCT04343313	IDE Number G200185	CMS Approval Date 2024-02-06	Category A
Study Title A Prospective, Multi-Center, Non-Randomized, SinGle-Arm Study of the BDTM Low ProfILe Vascular Covered Stent in PerIpheral ArTerY Disease (AGILITY)	Sponsor Name Bard Peripheral Vascular, Inc.	NCT Number NCT06111469	IDE Number G230162	CMS Approval Date 2024-02-06	Category B
Study Title Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF	Sponsor Name Massachusetts General Hospital	NCT Number NCT06099730	IDE Number G230258	CMS Approval Date 2024-01-31	Category B
Study Title A Multi-center, National, Open Label, Prospective Study to Evaluate the Safety, Usability and Performance of the V-LAP™ System, for Wirelessly Measuring and Monitoring Left Atrial Pressure (Lap) in Patients With Advanced CHF	Sponsor Name Vectorious Medical Technologies Ltd.	NCT Number NCT06147336	IDE Number G220071	CMS Approval Date 2024-01-30	Category A
Study Title The THOR IDE Study	Sponsor Name Philips Clinical & Medical Affairs Global	NCT Number NCT05916950	IDE Number G210047	CMS Approval Date 2024-01-19	Category B
Study Title A Multicentre, Single-Arm, Pivotal Study to Evaluate the Safety and Efficacy of the Vivasure PerQseal® Closure Device System When Used to Achieve Haemostasis of Common Femoral Arteriotomies Created by 12 to 22 F Sheaths in Patients Undergoing Percutaneou...	Sponsor Name Vivasure Medical Limited	NCT Number NCT05653336	IDE Number G210227	CMS Approval Date 2024-01-12	Category B
Study Title Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial	Sponsor Name Mercy Health Ohio	NCT Number NCT05611242	IDE Number G230119	CMS Approval Date 2024-01-12	Category B
Study Title AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion	Sponsor Name Shape Memory Medical, Inc.	NCT Number NCT06029660	IDE Number G230212	CMS Approval Date 2024-01-12	Category B
Study Title Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)	Sponsor Name Innova Vascular, Inc.	NCT Number NCT06041594	IDE Number G230204	CMS Approval Date 2024-01-12	Category B
Study Title PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System	Sponsor Name PROCEPT BioRobotics	NCT Number NCT06054867	IDE Number G230155	CMS Approval Date 2024-01-03	Category B
Study Title Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH™ SF Catheter with the TRUPULSE™ Generator for treatment of drug refractory symptomatic Paroxysmal Atrial Fibrillation (PAF) SmartPulse PAF	Sponsor Name Biosense Webster, Inc.	NCT Number NCT06144632	IDE Number G230170	CMS Approval Date 2023-12-21	Category B
Study Title Pulsed Field Ablation for Long-Standing Persistent Atrial Fibrillation (LS-PersAFone)	Sponsor Name Vivek Reddy	NCT Number NCT06128174	IDE Number G230169	CMS Approval Date 2023-12-21	Category B
Study Title Niyad™	Sponsor Name AcelRx Pharmaceuticals, Inc.	NCT Number NCT06150742	IDE Number G210026	CMS Approval Date 2023-12-20	Category A
Study Title A Prospective Randomized Multicenter Global Study Comparing Pulsed Field Ablation (PFA) Versus Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation	Sponsor Name Boston Scientific Corporation	NCT Number NCT06096337	IDE Number G230249	CMS Approval Date 2023-12-20	Category B
Study Title Evaluation of the Performance Of The VenusP-ValveTM System in Patients With Native RVOT Dysfunction	Sponsor Name Venus MedTech (HangZhou) Inc.	NCT Number NCT06010563	IDE Number G230086	CMS Approval Date 2023-12-14	Category B
Study Title Radioembolization Oncology Trial Utilizing Transarterial Eye90 (ROUTE 90) for the Treatment of Hepatocellular Carcinoma (HCC)	Sponsor Name ABK Biomedical	NCT Number NCT05953337	IDE Number G230077	CMS Approval Date 2023-12-13	Category B
Study Title A Prospective, Multi-Center, Open Label, Randomized Control Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class II Heart Failure Patients	Sponsor Name Endotronix, Inc.	NCT Number NCT05934487	IDE Number G190020	CMS Approval Date 2023-12-12	Category B
Study Title Prospective Pilot Study on Geniculate Artery Embolization for Treatment of Persistent Knee Pain Post Total Knee Arthroplasty	Sponsor Name NYU Langone Health	NCT Number NCT06134817	IDE Number G230245	CMS Approval Date 2023-12-08	Category B
Study Title BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treatment	Sponsor Name Orchestra BioMed, Inc	NCT Number NCT06059638	IDE Number G230209	CMS Approval Date 2023-12-07	Category B
Study Title Use of the Impella BTR™ in Patients With Heart Failure: An Early Feasibility Study	Sponsor Name Abiomed Inc.	NCT Number NCT05291884	IDE Number G210338	CMS Approval Date 2023-12-07	Category A
Study Title IonMAN II Trial- Early Feasibility Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System	Sponsor Name Medinol Ltd.	NCT Number NCT06071702	IDE Number G220276	CMS Approval Date 2023-12-07	Category B
Study Title Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism	Sponsor Name Imperative Care, Inc.	NCT Number NCT06062329	IDE Number G230071	CMS Approval Date 2023-11-30	Category B
Study Title SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study	Sponsor Name VenoStent	NCT Number NCT06001827	IDE Number G230097	CMS Approval Date 2023-11-30	Category B
Study Title A Prospective, Multicenter, Clinical Trial Designed to Evaluate the Safety and Feasibility of the ELIOS System to Reduce Intraocular Pressure in Patients With Primary Open-Angle Glaucoma as a Standalone Procedure	Sponsor Name Elios Vision, Inc.	NCT Number NCT05999006	IDE Number G200311	CMS Approval Date 2023-11-30	Category B
Study Title Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation	Sponsor Name VDyne, Inc.	NCT Number NCT05848284	IDE Number G210172	CMS Approval Date 2023-11-30	Category A
Study Title Controlled Arterial Protection to Ultimately Remove Embolic Material	Sponsor Name EmStop Inc	NCT Number NCT06103591	IDE Number G220288	CMS Approval Date 2023-11-30	Category B
Study Title A Prospective Single-Arm Multicenter Study Evaluating Use of the CORA Catheters for the Crossing of Coronary Chronic Total Occlusions	Sponsor Name ReFlow Medical, Inc.	NCT Number NCT05848232	IDE Number G230085	CMS Approval Date 2023-11-20	Category B
Study Title A Phase III, Randomized, Multicenter, Investigational, Open Label Clinical Trial That Will Examine Whether Treatment With Endovascular Thrombectomy is Superior to Standard Medical Therapy Alone in Patients Who Suffer a Distal Medium Vessel Occlusion Ische...	Sponsor Name Raul Nogueira	NCT Number NCT05983757	IDE Number G220231	CMS Approval Date 2023-11-16	Category B
Study Title Prospective, Multicenter, Single-Arm IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD Duo Study)	Sponsor Name Shockwave Medical, Inc.	NCT Number NCT05966662	IDE Number G230172	CMS Approval Date 2023-11-09	Category B
Study Title PramStat Sealant Patch	Sponsor Name Sealonix, Inc.	NCT Number NCT06010147	IDE Number G230138	CMS Approval Date 2023-11-09	Category B
Study Title Per-oral Pancreatoscopy-guided Lithotripsy vs. Extracorporeal Shock Wave Lithotripsy in Chronic Pancreatitis	Sponsor Name University of Colorado, Denver	NCT Number NCT04115826	IDE Number G220209	CMS Approval Date 2023-11-09	Category B
Study Title Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy	Sponsor Name Vivek Reddy	NCT Number NCT06056557	IDE Number G230124	CMS Approval Date 2023-11-09	Category B
Study Title Evaluation of the GORE® Ascending Stent Graft in the Treatment of Lesions of the Ascending Aorta	Sponsor Name W.L.Gore & Associates	NCT Number NCT05800743	IDE Number G230034	CMS Approval Date 2023-11-02	Category B
Study Title Safety and Performance of the ThecaFlex DRx™ System Port and Catheter for Chronic Intrathecal Access, Cerebrospinal Fluid (CSF) Aspiration, and DElivery of Nusinersen in Spinal Muscular Atrophy (SMA) Patients Resistant to Lumbar PunctuRE Trial (PIERRE)	Sponsor Name Alcyone Therapeutics, Inc.	NCT Number NCT05866419	IDE Number G220289	CMS Approval Date 2023-11-02	Category B
Study Title Evaluation of Acute Mechanical Revascularization in Large Vessel Occlusion Stroke with Minor Symptoms (NIHSS < 6) in Patients Last Seen Well < 24 Hours – Minor Stroke Therapy Evaluation (IN EXTREMIS - MOSTE)	Sponsor Name University Hospital, Montpellier	NCT Number NCT03796468	IDE Number G220138	CMS Approval Date 2023-11-02	Category B
Study Title A Prospective, Multicenter, Randomized Clinical Investigation Evaluating GATT-Patch for Hemostasis During Minimally Invasive Liver and Gallbladder Surgery	Sponsor Name GATT Technologies BV	NCT Number NCT05900037	IDE Number G230105	CMS Approval Date 2023-10-24	Category A
Study Title GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA (MOTION)	Sponsor Name Merit Medical Systems, Inc.	NCT Number NCT05818150	IDE Number G220318	CMS Approval Date 2023-10-20	Category B
Study Title Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder for Bladder Cancer Treatment, MODERN Study	Sponsor Name National Cancer Institute (NCI)	NCT Number NCT05987241	IDE Number G230039	CMS Approval Date 2023-10-19	Category B
Study Title Cardiac Resynchronization Therapy Using His/Left Bundle Branch Pacing vs Biventricular Pacing With a Left Ventricular Epicardial Lead in Patients With Heart Failure (HF) With Left Ventricular Ejection Fraction (LVEF) ≥ 50% and With Either a Wide QRS Com...	Sponsor Name Baylor College of Medicine	NCT Number NCT05650658	IDE Number G230050	CMS Approval Date 2023-10-19	Category B
Study Title The PROTEMBO Trial	Sponsor Name Protembis GmbH	NCT Number NCT05873816	IDE Number G220032	CMS Approval Date 2023-10-12	Category A
Study Title Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer (VAPOR 2)	Sponsor Name Francis Medical Inc.	NCT Number NCT05683691	IDE Number G220303	CMS Approval Date 2023-10-12	Category B
Study Title GORE® VIABIL® Biliary Endoprosthesis for the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis	Sponsor Name W.L.Gore & Associates	NCT Number NCT05820009	IDE Number G230011	CMS Approval Date 2023-10-12	Category B
Study Title Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus (PATENT-E)	Sponsor Name GIE Medical	NCT Number NCT05561114	IDE Number G220163	CMS Approval Date 2023-09-29	Category B
Study Title Randomized Study of the pdSTIM™ System (Phrenic Nerve to Diaphragm STIMulation) in Failure to Wean Mechanically Ventilated Patients (ReInvigorate)	Sponsor Name Stimdia Medical Inc.	NCT Number NCT05998018	IDE Number G220305	CMS Approval Date 2023-09-21	Category B
Study Title The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation (REACT-AF)	Sponsor Name Johns Hopkins University	NCT Number NCT05836987	IDE Number G230084	CMS Approval Date 2023-09-21	Category B
Study Title EFS of the DUO System for Tricuspid Regurgitation (TANDEM II) (TANDEM II)	Sponsor Name CroiValve Limited	NCT Number NCT05913908	IDE Number G220264	CMS Approval Date 2023-09-14	Category A
Study Title Clinical trial to investigate the safety and effectiveness of a hydrophilic EMV toric lens RAO210T in the correction of aphakia and post-operative corneal astigmatism	Sponsor Name Sierra Clinical Services LLC	NCT Number NCT05985304	IDE Number G230072	CMS Approval Date 2023-09-14	Category B
Study Title A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus-Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis	Sponsor Name Concept Medical Inc.	NCT Number NCT05908331	IDE Number G210107	CMS Approval Date 2023-09-08	Category B
Study Title IMpella-Protected cArdiaC Surgery Trial (IMPACT) (IMPACT)	Sponsor Name Abiomed Inc.	NCT Number NCT05529654	IDE Number G210059	CMS Approval Date 2023-09-08	Category B
Study Title Zenith® Fenestrated+ Endovascular Graft Clinical Study	Sponsor Name Cook Research Incorporated	NCT Number NCT04875429	IDE Number G210110	CMS Approval Date 2023-09-05	Category B
Study Title ULTRASOUND-BASED RENAL SYMPATHETIC DENERVATION AS ADJUNCTIVE UPSTREAM THERAPY DURING ATRIAL FIBRILLATION – REDO ABLATION PROCEDURES: A Pilot Study	Sponsor Name Vivek Reddy	NCT Number NCT05988411	IDE Number G190234	CMS Approval Date 2023-09-05	Category B
Study Title Promoting Healing of Injured Nerves with Electrical Stimulation Therapy [PHINEST]	Sponsor Name Checkpoint Surgical Inc.	NCT Number NCT05884125	IDE Number G220015	CMS Approval Date 2023-09-05	Category B
Study Title XVIVO Heart Preservation System (XHPS) with Supplemented XVIVO Heart Solution (SXHS)	Sponsor Name XVIVO Perfusion, Inc.	NCT Number NCT05881278	IDE Number G220113	CMS Approval Date 2023-08-24	Category B
Study Title Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears	Sponsor Name InGeneron, Inc.	NCT Number NCT03752827	IDE Number BB16956	CMS Approval Date 2023-08-24	Category B
Study Title Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis	Sponsor Name The Cleveland Clinic	NCT Number NCT04990128	IDE Number BB27066	CMS Approval Date 2023-08-24	Category B
Study Title An Open Label, Randomized Controlled Study, Evaluating the Safety of RD2 Ver.02 For the Management of Anal Fistulas	Sponsor Name RedDress Ltd.	NCT Number NCT05641844	IDE Number 28705/3	CMS Approval Date 2023-08-10	Category B
Study Title Treatment of Acute Pulmonary Embolism with the Inquis Medical Thrombectomy System	Sponsor Name Inquis Medical, Inc.	NCT Number NCT05907564	IDE Number G230027	CMS Approval Date 2023-08-10	Category B
Study Title Treatment of PAF With the Synaptic System (Sensation)	Sponsor Name Synaptic Medical Corporation	NCT Number NCT05905835	IDE Number G230112	CMS Approval Date 2023-08-08	Category B
Study Title Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction (FIRE-HFpEF)	Sponsor Name Medtronic Cardiac Rhythm and Heart Failure	NCT Number NCT05839730	IDE Number G220190	CMS Approval Date 2023-07-27	Category B
Study Title Neuroguard IEP® Direct 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP® Direct System)	Sponsor Name Contego Medical, Inc.	NCT Number NCT05845710	IDE Number G230015	CMS Approval Date 2023-07-27	Category B
Study Title DRAIN-HF: Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure	Sponsor Name Procyrion	NCT Number NCT05677100	IDE Number G200294	CMS Approval Date 2023-07-20	Category B
Study Title RECOVER IV Trial	Sponsor Name Abiomed Inc.	NCT Number NCT05506449	IDE Number G220149	CMS Approval Date 2023-07-20	Category B
Study Title Millipede AspiRation for Revascularization in Stroke Study (MARRS)	Sponsor Name Perfuze	NCT Number NCT05714501	IDE Number G230001	CMS Approval Date 2023-07-13	Category B
Study Title Cryoablation for Monomorphic Ventricular Tachycardia Early Feasibility Study (EFS) (FULCRUM-VT)	Sponsor Name Adagio Medical	NCT Number NCT05675865	IDE Number G220229	CMS Approval Date 2023-07-13	Category B
Study Title Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases From Breast Carcinoma Involving the Spine	Sponsor Name Mayo Clinic	NCT Number NCT05746325	IDE Number G220128	CMS Approval Date 2023-06-29	Category B
Study Title Concurrent Optical and Magnetic Stimulation (COMS) for Treatment of Refractory Diabetic Foot Ulcer; a Prospective Randomized, Sham-controlled, Double-blinded, Pivotal Clinical Trial	Sponsor Name Piomic Medical	NCT Number NCT05758545	IDE Number G220277	CMS Approval Date 2023-06-20	Category B
Study Title Liverty™ TIPS Stent Graft	Sponsor Name Bard Peripheral Vascular, Inc.	NCT Number NCT05711316	IDE Number G220298	CMS Approval Date 2023-06-15	Category B
Study Title Shockwave Intravascular Lithotripsy System with the Shockwave Mini S Peripheral IVL Catheter	Sponsor Name Shockwave Medical	NCT Number NCT05858905	IDE Number G220300	CMS Approval Date 2023-06-15	Category B
Study Title The HistoSonics Edison System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY US)	Sponsor Name HistoSonics, Inc.	NCT Number NCT05820087	IDE Number G230008	CMS Approval Date 2023-06-15	Category B
Study Title eTrieve™ PE Kit for Endovascular Thrombectomy in Subjects with Acute Pulmonary Embolism	Sponsor Name Magneto Thrombectomy Solutions	NCT Number NCT05821426	IDE Number G230056	CMS Approval Date 2023-06-15	Category B
Study Title Early Feasibility Study of the FIRE1™ System in Heart Failure Patients	Sponsor Name Foundry Innovation & Research 1, Limited (FIRE1)	NCT Number NCT05763407	IDE Number G220284	CMS Approval Date 2023-06-08	Category B
Study Title Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms ALIVE-EA (American Less Invasive Ventricular Enhancement-Expanded Access	Sponsor Name BioVentrix	NCT Number NCT05710042	IDE Number G160013	CMS Approval Date 2023-05-18	Category B
Study Title A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation	Sponsor Name Kardium Inc.	NCT Number NCT05462145	IDE Number G220208	CMS Approval Date 2023-05-18	Category B
Study Title Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) Safety & Efficacy in Hysterectomy	Sponsor Name ZSX Medical LLC	NCT Number NCT05570916	IDE Number G230037	CMS Approval Date 2023-05-18	Category A
Study Title SELUTION SLR™ 014 ISR: A Prospective Randomized Single Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Subjects With In-stent Restenosis	Sponsor Name M.A. Med Alliance S.A.	NCT Number NCT04280029	IDE Number G220237	CMS Approval Date 2023-05-18	Category B
Study Title Multi-Cancer Early Detection - Real-World Evidence Program in the Medicare Population	Sponsor Name GRAIL	NCT Number NCT05673018	IDE Number G220255	CMS Approval Date 2023-05-18	Category B
Study Title A Prospective, Multi-Center, Single-Arm Clinical Trial of the Safety and Effectiveness of the Aptis PRUJ Prosthesis for the Treatment of Patients With Proximal Radial Ulna Joint Disorders	Sponsor Name Aptis Medical	NCT Number NCT05796908	IDE Number G190256	CMS Approval Date 2023-05-04	Category B
Study Title A Prospective, Randomized, Multicenter Evaluation of the Safety and Effectiveness of the EMBLOK Embolic Protection System During Transcatheter Aortic Valve Replacement	Sponsor Name Innovative Cardiovascular Solutions	NCT Number NCT05295628	IDE Number G220046	CMS Approval Date 2023-05-04	Category B
Study Title Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion	Sponsor Name Volta Medical	NCT Number NCT05477147	IDE Number G220162	CMS Approval Date 2023-04-28	Category B
Study Title Safety and Effectiveness of the Hip Innovation Technology Reverse Hip Replacement System in Primary Total Hip Arthroplasty: A Pivotal Study	Sponsor Name Hip Innovation Technology	NCT Number NCT05357378	IDE Number G210243	CMS Approval Date 2023-04-20	Category B
Study Title Early Feasibility Study (EFS) of the Magenta Elevate™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients Undergoing Non-emergent, High-risk Percutaneous Coronary Interventions	Sponsor Name Magenta Medical Ltd.	NCT Number NCT05727059	IDE Number G220308	CMS Approval Date 2023-04-20	Category B
Study Title A Prospective, Multicenter Randomized Controlled Trial (RCT) of the da Vinci® SP™ Surgical System vs Open Surgery in Nipple Sparing Mastectomy (NSM) Procedures	Sponsor Name Intuitive Surgical	NCT Number NCT05720039	IDE Number G220319	CMS Approval Date 2023-04-20	Category B
Study Title WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast Stroke Treatment)	Sponsor Name Philips Clinical & Medical Affairs Global	NCT Number NCT04701684	IDE Number G210378	CMS Approval Date 2023-04-13	Category B
Study Title Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)	Sponsor Name Varian, a Siemens Healthineers Company	NCT Number NCT05765175	IDE Number G220177	CMS Approval Date 2023-04-13	Category B
Study Title A Phase I/Ib Pilot Trial, Single Arm, Open Label, of Protein-Bound Paclitaxel, Cisplatin, and Gemcitabine (GCN) Combined With Tumor Treatment Fields (TTF) in Patient With Metastatic Pancreatic Adenocarcinoma	Sponsor Name Mayo Clinic	NCT Number NCT04605913	IDE Number G200217	CMS Approval Date 2023-04-13	Category A
Study Title Encore PFO Closure Device U.S. IDE Randomized Trial - The PerFOrm Trial	Sponsor Name Encore Medical Inc.	NCT Number NCT05537753	IDE Number G220115	CMS Approval Date 2023-04-06	Category B
Study Title A Multi-Center, Prospective, Historically Controlled Pivotal Trial Comparing the Safety and Effectiveness of the Synergy Disc to Anterior Cervical Discectomy and Fusion in Patients With Two-Level Symptomatic Cervical Degenerative Disc Disease (DDD)	Sponsor Name Synergy Spine Solutions	NCT Number NCT05740176	IDE Number G210118	CMS Approval Date 2023-03-31	Category B
Study Title A Randomized, Sham-controlled Trial of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW II)	Sponsor Name Edwards Lifesciences	NCT Number NCT05686317	IDE Number G180033	CMS Approval Date 2023-03-31	Category B
Study Title Early Feasibility Study of the Trisol System	Sponsor Name Trisol Medical	NCT Number NCT04905017	IDE Number G210103	CMS Approval Date 2023-03-31	Category A
Study Title Protect the Head to Head: A Safety and Efficacy Assessment of the Emboliner Embolic Protection Device	Sponsor Name Emboline	NCT Number NCT05684146	IDE Number G220033	CMS Approval Date 2023-03-23	Category B
Study Title Symplicity Spyral Renal Denervation System	Sponsor Name Medtronic	NCT Number NCT05116384	IDE Number G220017	CMS Approval Date 2023-03-16	Category A
Study Title Phase 2 Trial of Ablative MRI-guided Stereotactic Body Radiation Therapy and Tumor Treating Fields for Locally Advanced Pancreas Cancer	Sponsor Name Baptist Health South Florida	NCT Number NCT05679674	IDE Number G220281	CMS Approval Date 2023-03-16	Category A
Study Title DART 2.0: ctHPV-DNA Informed De-Escalated Adjuvant and Definitive Radiation Therapy	Sponsor Name Mayo Clinic	NCT Number NCT05541016	IDE Number G220182	CMS Approval Date 2023-02-17	Category B
Study Title Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone Cavities	Sponsor Name Elute, Inc.	NCT Number NCT05361941	IDE Number G210130	CMS Approval Date 2023-02-17	Category B
Study Title Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Iliofemoral Venous Obstruction	Sponsor Name W.L.Gore & Associates	NCT Number NCT05489588	IDE Number G220169	CMS Approval Date 2023-01-19	Category B
Study Title REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT), a Phase I Prospective Randomized Controlled Trial	Sponsor Name Inova Health Care Services	NCT Number NCT05652218	IDE Number G220157	CMS Approval Date 2023-01-12	Category B
Study Title A Single-Arm, Single-Center, Non-Randomized, Prospective Clinical Study to Evaluate the Safety and Effectiveness of Physician Modified Endograft for Complex Abdominal and Thoracoabdominal Aortic Aneurysm Repair	Sponsor Name University of California, San Diego	NCT Number NCT05339061	IDE Number G220057	CMS Approval Date 2023-01-12	Category B
Study Title A Multicenter, Prospective, Randomized, Controlled, Open Label Trial to Evaluate the Safety and Efficacy of Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression in Patients Who Have Undergone Endovascular Procedures Utilizing up to 12F...	Sponsor Name Cordis Corporation	NCT Number NCT05554471	IDE Number G220147	CMS Approval Date 2023-01-12	Category B
Study Title Remote Ischemic PreConditioning Provides Neuroprotection: A Phase 2, Single Center, Randomized, Double-Blind, Sham-Controlled, Safety and Efficacy Study Evaluating the Use of Remote Ischemic Preconditioning in Patients Undergoing Endovascular Repair of Br...	Sponsor Name Sebastian Koch	NCT Number NCT03814850	IDE Number G180220	CMS Approval Date 2023-01-05	Category B
Study Title Evaluation of Spinal Cord Ischemia and Mortality and Morbidity After Endovascular Repair of Pararenal and Thoracoabdominal Aortic Aneurysm Using Surgeon-Modified Endografts	Sponsor Name Konstantinos Arnaoutakis	NCT Number NCT05195905	IDE Number G210245	CMS Approval Date 2022-12-29	Category B
Study Title Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens, Model DEN00V	Sponsor Name Johnson & Johnson Surgical Vision, Inc.	NCT Number NCT05574959	IDE Number G220225	CMS Approval Date 2022-12-23	Category B
Study Title Viper Catheter System	Sponsor Name EndovascularEngineering	NCT Number NCT05597891	IDE Number G220252	CMS Approval Date 2022-12-22	Category B
Study Title Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial	Sponsor Name AtriCure, Inc.	NCT Number NCT05478304	IDE Number G220093	CMS Approval Date 2022-12-22	Category B
Study Title Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Inferior Vena Cava Obstruction With or Without Combined Iliofemoral Obstruction	Sponsor Name W.L.Gore & Associates	NCT Number NCT05409976	IDE Number G220109	CMS Approval Date 2022-12-19	Category B
Study Title Comparison of Left Bundle Branch Area Versus Right Ventricular Septal Pacing in Patients With High-degree Conduction Disease After Transcatheter Aortic Valve Replacement	Sponsor Name Main Line Health	NCT Number NCT05541679	IDE Number G220061	CMS Approval Date 2022-12-09	Category B
Study Title A Phase II Trial of CD34+ Enriched Transplants From HLA-Compatible Related or Unrelated Donors for Treatment of Patients With Leukemia or Lymphoma	Sponsor Name Baptist Health South Florida	NCT Number NCT05565105	IDE Number BB19519	CMS Approval Date 2022-12-08	Category B
Study Title A Feasibility Study of the NEURESCUE Device as an Adjunct to In-Hospital Cardiac Arrest	Sponsor Name Neurescue Inc	NCT Number NCT05444049	IDE Number G200313	CMS Approval Date 2022-12-08	Category B
Study Title Treatment of Ruptured Wide-Neck Aneurysms with Nautilus Device Assisted Occlusion (TORNADO)	Sponsor Name Vastrax	NCT Number NCT05550571	IDE Number G210182	CMS Approval Date 2022-12-08	Category B
Study Title A Prospective, Multicenter, Single Blind, Randomized Controlled Trial Evaluating the Safety and Effectiveness of the MOTIV Sirolimus-Eluting Bioresorbable Vascular Scaffold Compared With Plain Balloon Angioplasty for the Treatment of Infrapopliteal Lesion...	Sponsor Name REVA Medical, Inc.	NCT Number NCT05406622	IDE Number G210315	CMS Approval Date 2022-12-08	Category A
Study Title A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL)	Sponsor Name ReFlow Medical, Inc.	NCT Number NCT05358353	IDE Number G220087	CMS Approval Date 2022-12-01	Category B
Study Title A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ Device (The ShortCut™ Study)	Sponsor Name Pi-cardia	NCT Number NCT04952909	IDE Number G220165	CMS Approval Date 2022-11-17	Category B
Study Title A Prospective, Multicenter, Randomized Clinical Investigation Evaluating the Safety and Efficacy of GATT-Patch Versus TachoSil for Hemostasis During Open Liver Surgery	Sponsor Name GATT Technologies BV	NCT Number NCT05385952	IDE Number G210325	CMS Approval Date 2022-11-17	Category A
Study Title Safety and Effectiveness of Surgeon-Modified Fenestrated and Branched Endografts in Treating Subjects With Complex Aortic Aneurysms	Sponsor Name Jesse Manunga, MD	NCT Number NCT05531084	IDE Number G220004	CMS Approval Date 2022-11-17	Category B
Study Title Safety and Efficacy of Elbow Artery Embolization (EAE) for the Treatment of Lateral Epicondylitis	Sponsor Name Siddharth Padia, MD	NCT Number NCT05325242	IDE Number G210372	CMS Approval Date 2022-11-09	Category B
Study Title FlowTriever Pulmonary Embolectomy Clinical Study - FlowTriever2	Sponsor Name Inari Medical	NCT Number NCT05560763	IDE Number G210141	CMS Approval Date 2022-11-03	Category B
Study Title Genicular Artery Embolization (GAE) for the Treatment of Chronic Post Knee Arthroplasty Pain	Sponsor Name Brigham and Women's Hospital	NCT Number NCT05248308	IDE Number G210321	CMS Approval Date 2022-11-03	Category B
Study Title A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Efficacy of the SELUTION SLR™ 018 Drug Eluting Balloon in the Treatment of Subjects With Femoropopliteal Artery Lesions	Sponsor Name M.A. Med Alliance S.A.	NCT Number NCT05132361	IDE Number G210320	CMS Approval Date 2022-10-27	Category B
Study Title THUNDER: Acute Ischemic Stroke Study With the Penumbra System® Including Thunderbolt™ Aspiration Tubing	Sponsor Name Penumbra Inc.	NCT Number NCT05437055	IDE Number G220126	CMS Approval Date 2022-10-24	Category B
Study Title Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Renal Denervation in Patients With Uncontrolled Stage 2 Hypertension	Sponsor Name SoniVie Inc.	NCT Number NCT05372679	IDE Number G220102	CMS Approval Date 2022-10-13	Category B
Study Title A Pivotal Clinical Trial Evaluating the Safety and Effectiveness of Adherus™ AutoSpray and Adherus™ AutoSpray ET Dural Sealant When Used as a Dural Sealant in Spinal Procedures	Sponsor Name Stryker Craniomaxillofacial	NCT Number NCT04498026	IDE Number G190134	CMS Approval Date 2022-10-06	Category B
Study Title Responder-HF Trial	Sponsor Name Corvia Medical	NCT Number NCT05425459	IDE Number G150210	CMS Approval Date 2022-09-20	Category B
Study Title A Prospective Multicenter Single-Arm Staged Study to Evaluate the Safety and Effectiveness of Embrace™ Hydrogel Embolic For Transcatheter Embolization of Arterial Bleeding in Solid Organs and Peripheral Arteries	Sponsor Name Instylla, Inc.	NCT Number NCT05364502	IDE Number G210241	CMS Approval Date 2022-08-25	Category B
Study Title BIOTRONIK Conduction System Pacing With the Solia Lead	Sponsor Name Biotronik, Inc.	NCT Number NCT05251363	IDE Number G210349	CMS Approval Date 2022-08-25	Category B
Study Title Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans With Hemopurifier® Device	Sponsor Name Aethlon Medical Inc.	NCT Number NCT04595903	IDE Number G070038	CMS Approval Date 2022-08-25	Category B
Study Title Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial)	Sponsor Name HealthCore-NERI	NCT Number NCT05268094	IDE Number G210212	CMS Approval Date 2022-08-25	Category B
Study Title Time in Glucose Hospital Target (TIGHT) - A Randomized Clinical Trial to Evaluate the Use of CGM to Achieve a Mean Glucose Target of 90 to 130 mg/dL Without Hypoglycemia in Hospitalized Adults With Type 2 Diabetes	Sponsor Name Jaeb Center for Health Research	NCT Number NCT05135676	IDE Number G210298	CMS Approval Date 2022-08-12	Category B
Study Title A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation	Sponsor Name Boston Scientific Corporation	NCT Number NCT05443594	IDE Number G220079	CMS Approval Date 2022-08-10	Category B
Study Title A Prospective, Multicenter, Single-arm Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA Study)	Sponsor Name Vascular Solutions LLC	NCT Number NCT04862689	IDE Number G200321	CMS Approval Date 2022-08-10	Category B
Study Title TVMR With the Innovalve System Trial - Early Feasibility Study	Sponsor Name Innovalve Bio Medical Ltd.	NCT Number NCT04919980	IDE Number G210083	CMS Approval Date 2022-08-10	Category A
Study Title A Multicentre, Prospective, Randomized, Parallel Group, Open-label Design to Determine the Efficacy and Safety of Endovascular Thrombectomy for Ischemic Stroke Patients With Symptomatic Acute Medium Vessel Intracranial Occlusions	Sponsor Name Dr. Michael Hill, University of Calgary	NCT Number NCT05151172	IDE Number G220096	CMS Approval Date 2022-08-10	Category B
Study Title A Prospective, Randomized, Controlled, Double-Masked, Phased, Multi-Center Clinical Study to Evaluate the Safety and Efficacy of the LensGen® Juvene® Intraocular Lens	Sponsor Name LensGen, Inc.	NCT Number NCT05364983	IDE Number G200132	CMS Approval Date 2022-08-10	Category A
Study Title Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: The PROMISE III Trial	Sponsor Name LimFlow, Inc.	NCT Number NCT05313165	IDE Number G160156	CMS Approval Date 2022-07-28	Category B
Study Title SELUTION SLR™ 014 BTK: A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Below-the-Knee (BTK) Atherosclerotic Disease in Patients With Chr...	Sponsor Name M.A. Med Alliance S.A.	NCT Number NCT05055297	IDE Number G210342	CMS Approval Date 2022-07-28	Category B
Study Title A Prospective, Multi-Center Investigation of the da Vinci SP® Surgical System in Pulmonary Lobectomy and Thymectomy for Benign and Malignant Disease	Sponsor Name Intuitive Surgical	NCT Number NCT05150210	IDE Number G210237	CMS Approval Date 2022-07-18	Category B
Study Title Pre-pectoral Tissue Expander to Implant Breast Reconstruction with and without Mesh Assistance: Multicenter Randomized Controlled Trial	Sponsor Name University of California, Los Angeles	NCT Number NCT05190978	IDE Number G190311	CMS Approval Date 2022-07-18	Category B
Study Title A Prospective Multicenter Study of Transbronchial Microwave Ablation Using Robotic Assisted Bronchoscopy in Subjects with Oligometastatic Tumors in the Lung	Sponsor Name Ethicon, Inc.	NCT Number NCT05299606	IDE Number G210303	CMS Approval Date 2022-07-12	Category A
Study Title RNS® System Responsive Thalamic Stimulation for Primary Generalized Seizures (NAUTILUS) Study	Sponsor Name NeuroPace	NCT Number NCT05147571	IDE Number G210286	CMS Approval Date 2022-07-12	Category B
Study Title A Feasibility Evaluation of the Muse Magnetic Resonance Guided Focused Ultrasound System	Sponsor Name University of Utah	NCT Number NCT05291507	IDE Number G210365	CMS Approval Date 2022-07-12	Category A
Study Title Early Feasibility Clinical Study of the Nervive VitalFlow Stimulation System for Treatment of Acute Ischemic Stroke Patients	Sponsor Name Nervive, Inc.	NCT Number NCT04801225	IDE Number G200307	CMS Approval Date 2022-06-24	Category B
Study Title Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial	Sponsor Name Thomas G. Brott, M.D.	NCT Number NCT02089217	IDE Number G130221	CMS Approval Date 2022-06-24	Category B
Study Title The Revitalize Trial: Reducing Vaginal Atrophy With Fractional CO2 Laser for Breast Cancer Survivors	Sponsor Name Alliance for Clinical Trials in Oncology	NCT Number NCT05379153	IDE Number G210180	CMS Approval Date 2022-06-23	Category B
Study Title Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism	Sponsor Name Angiodynamics, Inc.	NCT Number NCT05318092	IDE Number G210308	CMS Approval Date 2022-06-16	Category B
Study Title Study on the Safety and Effectiveness of APrevent® VOIS Implants for Treatment in Patients With Unilateral Vocal Fold Paralysis (UVFP) - a Two-Part, Open-Label, Non-Randomized Multicenter Study	Sponsor Name APrevent Biotech GmbH	NCT Number NCT05119842	IDE Number G200355	CMS Approval Date 2022-06-16	Category B
Study Title Use of the Impella ECP in Patients Undergoing an Elective or Urgent High-Risk Percutaneous Coronary Intervention	Sponsor Name Abiomed Inc.	NCT Number NCT05334784	IDE Number G200126	CMS Approval Date 2022-06-16	Category B
Study Title Clinical Investigation of the Safety and Effectiveness of FINEVISION HP Trifocal IOL	Sponsor Name Beaver-Visitec International, Inc.	NCT Number NCT04176965	IDE Number G210165	CMS Approval Date 2022-06-01	Category B
Study Title Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia	Sponsor Name AtriCure, Inc.	NCT Number NCT05280093	IDE Number G210309	CMS Approval Date 2022-05-26	Category B
Study Title Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System (AdmIRE)	Sponsor Name Biosense Webster, Inc.	NCT Number NCT05293639	IDE Number G220034	CMS Approval Date 2022-05-19	Category B
Study Title A Prospective, Randomized, Controlled, Interventional Clinical Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical MonoPoint® Reperfusion System for Aspiration Embolectomy in Acute Ischemic Stroke Patients (SUMMIT MAX)	Sponsor Name Route 92 Medical, Inc.	NCT Number NCT05018650	IDE Number G210002	CMS Approval Date 2022-05-04	Category B
Study Title Stage 2B of: A Pivotal, Prospective, Three-Stage, Single-Arm Study of Focal Ablation of the Prostate With NanoTherm® Therapy System for a Limited-Volume, Clinically Localized, Intermediate-Risk Prostate Cancer	Sponsor Name MagForce USA	NCT Number NCT05010759	IDE Number G150104	CMS Approval Date 2022-05-04	Category B
Study Title Prospective, Multi-center, Randomized Trial of the Protect PNS for Refractory Overactive Bladder (OAB) – “GUARDIAN” Study	Sponsor Name Micron Medical Corporation	NCT Number NCT04589507	IDE Number G200227	CMS Approval Date 2022-04-28	Category B
Study Title A Randomized Cross-Over Trial of Deep Brain Stimulation (DBS) of the Posterior Subthalamic Area (PSA), Ventral Intermediate Nucleus of the Thalamus (VIM), and VIM+PSA on Essential Tremor (ET)	Sponsor Name St. Joseph's Hospital and Medical Center, Phoenix	NCT Number NCT05096572	IDE Number G210238	CMS Approval Date 2022-04-07	Category B
Study Title The SEAL TO HEAL Study: Study to EvALuate Time TO HEmostasis of AbsorbaSeaL	Sponsor Name CyndRx	NCT Number NCT05234749	IDE Number G210374	CMS Approval Date 2022-04-07	Category B
Study Title A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating Bilateral-Subthalamic Nucleus Deep Brain Stimulation in Subjects with Early Stage Parkinson’s Disease	Sponsor Name VUMC	NCT Number NCT01984151	IDE Number G050016	CMS Approval Date 2022-03-23	Category B
Study Title Use of the Impella ECP in Patients Undergoing an Elective High-Risk Percutaneous Coronary Intervention: An Early Feasibility Study	Sponsor Name Abiomed Inc.	NCT Number NCT04477603	IDE Number G200126	CMS Approval Date 2022-03-23	Category B
Study Title A Prospective, Multi-Center, Open-Label Assessment of Efficacy and Safety of Quanta SC+ for Home Hemodialysis	Sponsor Name Quanta Dialysis Technologies Ltd	NCT Number NCT04975880	IDE Number G200362	CMS Approval Date 2022-03-17	Category B
Study Title Early Feasibility Study of the Vivasure PerQseal®+ (PerQseal® Plus) Vascular Closure Device when used to Achieve Hemostasis of Common Femoral Arteriotomies Created by 14 to 22 F Sheaths in Patients Undergoing Percutaneous Transcatheter Procedures	Sponsor Name Vivasure	NCT Number NCT05163548	IDE Number G210227	CMS Approval Date 2022-03-17	Category B
Study Title Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) - FASTR Trial	Sponsor Name Reprieve Cardiovascular, Inc	NCT Number NCT05174312	IDE Number G210258	CMS Approval Date 2022-03-17	Category B
Study Title Bariatric Embolization of Arteries With Imaging Visible Embolics	Sponsor Name Johns Hopkins University	NCT Number NCT04197336	IDE Number G190208	CMS Approval Date 2022-03-17	Category B
Study Title A ProspEctive, Single ARm, Multi-center Clinical InveStigation to EValuatE the Safety and Effectiveness of AMDS in the TREatment of Acute DeBakey Type I Dissection: PERSEVERE	Sponsor Name CryoLife, Inc.	NCT Number NCT05174767	IDE Number G210218	CMS Approval Date 2022-03-03	Category B
Study Title Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever	Sponsor Name Rapid Medical	NCT Number NCT05152524	IDE Number G200212	CMS Approval Date 2022-03-03	Category A
Study Title Prospective Multicenter MANTA™ Vascular Closure Device Ultrasound Guided Closure Study	Sponsor Name Essential Medical, Inc.	NCT Number NCT05142566	IDE Number G210288	CMS Approval Date 2022-02-10	Category B
Study Title Mepitel Film for the Reduction of Radiation Dermatitis in Breast Cancer Patients Undergoing Post-Mastectomy Radiation Therapy: A Randomized Phase III Clinical Trial	Sponsor Name Alliance for Clinical Trials in Oncology	NCT Number NCT04989504	IDE Number G200248	CMS Approval Date 2022-02-10	Category B
Study Title Flow Regulation by Opening the SepTum in Patients With Heart Failure; a Prospective, Randomized, Sham-controlled, Double-blind, Global Multicenter Study	Sponsor Name Occlutech International AB	NCT Number NCT05136820	IDE Number G210281	CMS Approval Date 2022-01-27	Category B
Study Title Assessment of Implantable CCM in the Heart Failure Group With Higher Ejection Fraction	Sponsor Name Impulse Dynamics	NCT Number NCT05064709	IDE Number G200042	CMS Approval Date 2022-01-27	Category B
Study Title Treatment of Persistent Atrial Fibrillation With the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System	Sponsor Name Affera, Inc.	NCT Number NCT05120193	IDE Number G210170	CMS Approval Date 2022-01-13	Category B
Study Title Cephea Mitral Valve System	Sponsor Name Abbott	NCT Number NCT05061004	IDE Number G210284	CMS Approval Date 2022-01-13	Category A
Study Title A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon (EXPANSE-PTCA)	Sponsor Name Infraredx	NCT Number NCT04985773	IDE Number G210195	CMS Approval Date 2021-12-30	Category B
Study Title A Prospective, Multicenter, Pivotal Study With Randomized Controlled Prophylactic and Independent Therapeutic Cohorts to Evaluate the Safety and Efficacy of an Absorbable Vena Cava Filter for Pulmonary Embolism Prevention	Sponsor Name Adient Medical	NCT Number NCT05127915	IDE Number G200251	CMS Approval Date 2021-12-30	Category B
Study Title A Multicenter, Prospective, Open-label, Randomized Controlled Clinical Trial to Compare the Safety and Effectiveness of the VitaSmart Liver Machine Perfusion System With Static Cold Storage for Organ Preservation Prior to Liver Transplantation	Sponsor Name Bridge to Life Ltd.	NCT Number NCT05045794	IDE Number G210056	CMS Approval Date 2021-12-09	Category B
Study Title PERFORM Stemless Reverse	Sponsor Name Tornier, Inc	NCT Number NCT05082987	IDE Number G210145	CMS Approval Date 2021-12-09	Category B
Study Title Envi-SR	Sponsor Name NeuroVasc Technologies, Inc.	NCT Number NCT05107206	IDE Number G200131	CMS Approval Date 2021-12-09	Category B
Study Title Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions	Sponsor Name Samin Sharma, M.D., F.A.C.C., M.S.C.A.I.	NCT Number NCT04865588	IDE Number G210030	CMS Approval Date 2021-12-09	Category B
Study Title Epidural Prefrontal Cortical Stimulation (EpCS) in Severe Treatment Resistant Depression	Sponsor Name University of Minnesota	NCT Number NCT04124341	IDE Number G200030	CMS Approval Date 2021-12-09	Category B
Study Title SEAM Trial: Sutureless End to End Anastomosis by Magnetic Compression: A Study to Evaluate Safety and Effectiveness of Self-Forming Magnet (SFM) Anastomosis Device: A Historically Controlled Propensity Matched Study	Sponsor Name GI Windows, Inc.	NCT Number NCT05046730	IDE Number G210230	CMS Approval Date 2021-12-09	Category B
Study Title The Cardiac Pulmonary Nerve Stimulation (CPNS) Pilot Study	Sponsor Name Cardionomic Inc.	NCT Number NCT04814134	IDE Number G210003	CMS Approval Date 2021-11-18	Category B
Study Title Dorsal Root Ganglion Stimulation Outcomes for the Treatment of Mechanical Knee Pain Among Patients With Osteoarthritis of the Surgical and Non-surgical Knee	Sponsor Name Kenneth B Chapman	NCT Number NCT05103527	IDE Number G210274	CMS Approval Date 2021-11-18	Category B
Study Title ACCEL® Absorbable Hemostat Powder Clinical Trial	Sponsor Name Hemostasis, LLC	NCT Number NCT04728087	IDE Number G130018	CMS Approval Date 2021-11-18	Category B
Study Title Advanced Impella® SmartAssist® System for Patient Monitoring & Treatment: An Early Feasibility Study	Sponsor Name Abiomed Inc.	NCT Number NCT04465201	IDE Number G200093	CMS Approval Date 2021-11-18	Category B
Study Title A Prospective, Multicenter, Single-arm Investigation of the Ringer Perfusion Balloon Catheter Performed Under an Exception From Informed Consent (EFIC) (Ringer IDE Study)	Sponsor Name Vascular Solutions LLC	NCT Number NCT04849169	IDE Number G190148	CMS Approval Date 2021-11-18	Category B
Study Title Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II	Sponsor Name Neovasc Inc.	NCT Number NCT05102019	IDE Number G160196	CMS Approval Date 2021-11-18	Category B
Study Title An Early Feasibility Study Assessing the Safety, Technical Performance, and Efficacy of the Electrolytic eCLIPs Bifurcation System for the Treatment of Intracranial Bifurcation Aneurysms	Sponsor Name Evasc Medical Systems Corp.	NCT Number NCT04886505	IDE Number G210080	CMS Approval Date 2021-11-18	Category B
Study Title Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D): A Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate DrugSorb-ATR Removal of Apixaban and Rivaroxaban to Reduce Likelihood of Serious B...	Sponsor Name CytoSorbents, Inc	NCT Number NCT05093504	IDE Number G210263	CMS Approval Date 2021-11-18	Category B
Study Title A Randomized, Single-Blinded, Non-Inferiority Study Comparing AGN1 Local Osteo-Enhancement Procedure (LOEP) SV Kit Treatment of Vertebral Compression Fragility Fractures to PMMA Bone Cement Treatment	Sponsor Name AgNovos Healthcare, LLC	NCT Number NCT04835428	IDE Number G210063	CMS Approval Date 2021-11-04	Category B
Study Title Prospective Randomized Multi-center Controlled Clinical Investigation Comparing Patent Foramen Ovale (PFO) Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion	Sponsor Name Occlutech International AB	NCT Number NCT05069558	IDE Number G210167	CMS Approval Date 2021-11-04	Category B
Study Title Randomized, Two-arm, Multicenter Study to Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery	Sponsor Name Polyganics BV	NCT Number NCT04086550	IDE Number G200118	CMS Approval Date 2021-10-28	Category B
Study Title Feasibility of Hemodialysis With the GARNET Device in Chronic Hemodialysis Patients With a Bloodstream Infection	Sponsor Name Boa Biomedical, Inc.	NCT Number NCT04658017	IDE Number G170218	CMS Approval Date 2021-10-25	Category A
Study Title A Multi-Center Randomized-Controlled Trial To Evaluate The Safety And Feasibility of The Delivery Of Intracoronary Hyperoxemic Supersaturated Oxygen Therapy For 60 Minutes In Patients With St Elevation Myocardial Infarction (STEMI) And Cardiogenic Shock A...	Sponsor Name TherOx	NCT Number NCT04876040	IDE Number G210023	CMS Approval Date 2021-10-25	Category B
Study Title Early Feasibility Study of Thalamic Stimulation to Prevent Impaired Consciousness in Epilepsy	Sponsor Name Yale University	NCT Number NCT04897776	IDE Number G210045	CMS Approval Date 2021-10-25	Category A
Study Title M6®-C Artificial Cervical Disc Two-Level IDE Pivotal Study	Sponsor Name Spinal Kinetics	NCT Number NCT04982835	IDE Number G160173	CMS Approval Date 2021-10-23	Category B
Study Title Prospective, Multicenter Confirmatory Clinical Evaluation of Novilase® Interstitial Laser Therapy for the Focal Destruction of Malignant Breast Tumors ≤15 mm (BR-003)	Sponsor Name Novian Health Inc.	NCT Number NCT03463954	IDE Number G100102	CMS Approval Date 2021-10-22	Category B
Study Title Lead EvaluAtion for Defibrillation and Reliability (LEADR)	Sponsor Name Medtronic Cardiac Rhythm and Heart Failure	NCT Number NCT04863664	IDE Number G210150	CMS Approval Date 2021-10-15	Category B
Study Title Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue in an Intermediate-Risk Patient Population	Sponsor Name Angiodynamics, Inc.	NCT Number NCT04972097	IDE Number G210154	CMS Approval Date 2021-10-07	Category B
Study Title A Randomized, Blinded, Multi-site, Pilot Study to Evaluate Adenosine 2A Receptor Agonist (REGADENOSON) in the Rehabilitation of Marginal Donor Lungs	Sponsor Name University of Maryland, Baltimore	NCT Number NCT04521569	IDE Number G180190	CMS Approval Date 2021-10-07	Category B
Study Title BOLT: A Prospective, Multicenter Study of Patients With Deep Vein Thrombosis to Evaluate the Safety and Efficacy of the Indigo® Aspiration System	Sponsor Name Penumbra Inc.	NCT Number NCT05003843	IDE Number G210173	CMS Approval Date 2021-09-30	Category B
Study Title SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study	Sponsor Name SafeHeal Inc.	NCT Number NCT05010850	IDE Number G190110	CMS Approval Date 2021-09-30	Category A
Study Title Early Feasibility Study of AngioSafe Coronary CTO Crossing System (RESTOR-COR-1)	Sponsor Name AngioSafe, Inc	NCT Number NCT04939740	IDE Number G210076	CMS Approval Date 2021-09-23	Category B
Study Title Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization in Patients With Localized Prostate Carcinoma and Obstructive Lower Urinary Tract Symptoms	Sponsor Name H. Lee Moffitt Cancer Center and Research Institute	NCT Number NCT04879940	IDE Number G210009	CMS Approval Date 2021-09-17	Category B
Study Title Feasibility Pilot of Hepatic Arterial Infusion Chemotherapy in a Rural Catchment Area, Using the Codman Vascular Catheter With the Synchromed II Pump, for Patients With Unresectable Colorectal Cancer Liver Metastases or Unresectable Intrahepatic Cholangio...	Sponsor Name Michael J Cavnar, MD	NCT Number NCT04276090	IDE Number G190313	CMS Approval Date 2021-09-17	Category B
Study Title Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea	Sponsor Name Inspire Medical Systems, Inc.	NCT Number NCT04801771	IDE Number G200322	CMS Approval Date 2021-09-02	Category B
Study Title A Randomized Phase II Study of Systemic Chemotherapy With or Without HAI FUDR/Dexamethasone in Patients With Unresectable Intrahepatic Cholangiocarcinoma	Sponsor Name Memorial Sloan Kettering Cancer Center	NCT Number NCT04891289	IDE Number G200338	CMS Approval Date 2021-09-02	Category B
Study Title The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) Study	Sponsor Name Hancock Jaffe Laboratiores, Inc	NCT Number NCT04943172	IDE Number G210069	CMS Approval Date 2021-08-31	Category B
Study Title Promoting Healing Of Nerves Through Electrical Stimulation	Sponsor Name Checkpoint Surgical Inc.	NCT Number NCT04662320	IDE Number G200170	CMS Approval Date 2021-08-30	Category A
Study Title Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T): A Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate Reduction in Postoperative Bleeding by Removal of Ticagrelor With the Intraoperative Use of the DrugSorb-ATR Device in Pa...	Sponsor Name CytoSorbents, Inc	NCT Number NCT04976530	IDE Number G210081	CMS Approval Date 2021-08-26	Category B
Study Title Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation	Sponsor Name Volta Medical	NCT Number NCT04702451	IDE Number G210111	CMS Approval Date 2021-08-26	Category B
Study Title Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System In Transcarotid Embolectomy	Sponsor Name Silk Road Medical	NCT Number NCT04881162	IDE Number G200347	CMS Approval Date 2021-08-26	Category B
Study Title mpella-supported Off-pump Coronary Artery Bypass Grafting in High Risk Revascularizations: A Single Center Prospective Observational Study	Sponsor Name Medical College of Wisconsin	NCT Number NCT04339452	IDE Number G200024	CMS Approval Date 2021-08-06	Category B
Study Title First-in-Human Early Feasibility Study of Safety, Tolerability and Efficacy for a Multichannel Vestibular Implant in Individuals With Bilateral Severe-to-Profound Loss of Vestibular Sensation	Sponsor Name Johns Hopkins University	NCT Number NCT02725463	IDE Number G150198	CMS Approval Date 2021-08-06	Category B
Study Title AcQBlate Force Sensing Ablation System US IDE Study for Atrial Fibrillation (AcQForce AF)	Sponsor Name Acutus Medical	NCT Number NCT04904354	IDE Number G200177	CMS Approval Date 2021-08-06	Category B
Study Title The Early Feasibility Study of the Transcatheter Tricuspid Valve Replacement System Transfemoral System	Sponsor Name Medtronic Cardiovascular	NCT Number NCT04433065	IDE Number G200119	CMS Approval Date 2021-07-29	Category A
Study Title On-X Heart Valve - 17mm Aortic and 23mm Mitral	Sponsor Name On-X Life Technologies, Inc.	NCT Number NCT01812174	IDE Number G120115	CMS Approval Date 2021-07-29	Category B
Study Title Conduction System Pacing Optimized Therapy Study	Sponsor Name Medtronic	NCT Number NCT04905290	IDE Number G210088	CMS Approval Date 2021-07-22	Category B
Study Title EF-36/Keynote B36: A Pilot, Single Arm, Open-Label Study of Tumor Treating Fields(TTFields, 150 kHz) Concomitant With Pembrolizumab for First Line Treatment of Advanced or Metastatic Intrathoracic Non-small Cell Lung Cancer	Sponsor Name NovoCure GmbH	NCT Number NCT04892472	IDE Number G210071	CMS Approval Date 2021-07-22	Category B
Study Title First-in-human Prospective Study to Assess the Safety and Efficacy of the CEM-Cage and CEM-Plate	Sponsor Name ReVivo Medical, Corp.	NCT Number NCT04883411	IDE Number G210017	CMS Approval Date 2021-07-08	Category B
Study Title A Multicenter, Single-Arm, Pivotal Study to Evaluate the Safety and Efficacy of the CGuard™ Carotid Stent System When Used to Treat Symptomatic and Asymptomatic Carotid Artery Stenosis in Patients Undergoing Carotid Artery Stenting	Sponsor Name InspireMD	NCT Number NCT04900844	IDE Number G190185	CMS Approval Date 2021-07-01	Category B
Study Title Early Feasibility Study (EFS) of the Cardiac Implants Percutaneous Ring Annuloplasty System for the Treatment of Functional Tricuspid Regurgitation	Sponsor Name Cardiac Implants LLC	NCT Number NCT04890821	IDE Number G200272	CMS Approval Date 2021-07-01	Category A
Study Title Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA	Sponsor Name Cerenovus, Part of DePuy Synthes Products, Inc.	NCT Number NCT04816591	IDE Number G200310	CMS Approval Date 2021-06-17	Category B
Study Title Continued Access Protocol Study for the use of the OrganOx metra normothermic machine perfusion device in human liver transplantation	Sponsor Name OrganOx Ltd	NCT Number NCT04862156	IDE Number G140243	CMS Approval Date 2021-06-03	Category B
Study Title Early Feasibility Study of the Vivasure PerQseal® Closure Device System After Use of the Impella Device for Cardiogenic Shock or Protected Percutaneous Coronary Intervention	Sponsor Name Vivasure Medical Limited	NCT Number NCT04818541	IDE Number G210043	CMS Approval Date 2021-06-03	Category B
Study Title INTELLiVENT-ASV Software	Sponsor Name Hamilton Medical AG	NCT Number NCT04400643	IDE Number G200044	CMS Approval Date 2021-05-26	Category A
Study Title Low Frequency Therapeutic Ultrasound System Pivotal Clinical Trial	Sponsor Name Sonogenix	NCT Number NCT04877847	IDE Number G200245	CMS Approval Date 2021-05-26	Category A
Study Title AltaValve Early Feasibility Study Protocol	Sponsor Name 4C Medical Technologies, Inc.	NCT Number NCT03997305	IDE Number G190128	CMS Approval Date 2021-05-26	Category A
Study Title US IDE Study of the Contour NEurovasCular System™ for IntraCranial A neurysm Repair (NECC Trial)	Sponsor Name Cerus Endovascular, Ltd	NCT Number NCT04852783	IDE Number G210078	CMS Approval Date 2021-05-26	Category B
Study Title A Pre-market, Open-label Feasibility, Prospective, Single-arm Multicenter Feasibility Investigation of Hearing Performance Using the CI632 in Adults With Low-frequency Residual Hearing	Sponsor Name Cochlear	NCT Number NCT04741009	IDE Number G200267	CMS Approval Date 2021-05-20	Category B
Study Title A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection during Atrial Fibrillation Ablation	Sponsor Name Malini Madhavan	NCT Number NCT04685317	IDE Number G200134	CMS Approval Date 2021-05-20	Category B
Study Title Ultrasound Technology to Fragment and Reposition Urinary Stones	Sponsor Name University of Washington	NCT Number NCT04796792	IDE Number G200233	CMS Approval Date 2021-05-20	Category B
Study Title A Prospective, Multicenter, Open-label Single Arm Study Evaluating the Safety & Efficacy of Selective Internal Radiation Therapy Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients	Sponsor Name Sirtex Medical	NCT Number NCT04736121	IDE Number G200352	CMS Approval Date 2021-05-05	Category B
Study Title Human Factors Actual-Use Confirmatory Validation Study of the Eximis CS (Contained Segmentation) System ("Contain" Study)	Sponsor Name Eximis Surgical	NCT Number NCT04799210	IDE Number G200318	CMS Approval Date 2021-05-04	Category B
Study Title Proton Particle Therapy for Cardiac Arrhythmia Extracorporeal Energy Source Ablation of Cardiac Tissue: A First Stage Early Feasibility Study	Sponsor Name Douglas L. Packer, MD	NCT Number NCT04392193	IDE Number G200015	CMS Approval Date 2021-04-22	Category B
Study Title Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility Study	Sponsor Name Emory University	NCT Number NCT04714216	IDE Number G200280	CMS Approval Date 2021-04-22	Category B
Study Title GRAVITY: Genicular Artery Embolization Versus Observation for the Treatment of Symptomatic Knee Osteoarthritis: a Randomized Controlled Trial	Sponsor Name University of California, Los Angeles	NCT Number NCT04682652	IDE Number G200303	CMS Approval Date 2021-04-22	Category B
Study Title Cochlear Implant With Dexamethasone Eluting Electrode Array (The CI-DEX Study): Pivotal Study	Sponsor Name Cochlear	NCT Number NCT04750642	IDE Number G200098	CMS Approval Date 2021-04-22	Category B
Study Title Single-Center Investigational Device Exemption Trial: Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)	Sponsor Name Beth Israel Deaconess Medical Center	NCT Number NCT04746677	IDE Number G200288	CMS Approval Date 2021-04-16	Category B
Study Title Early Feasibility EXperience of Posterior Leaflet RestOration to REduce Functional Mitral Regurgitation (EXPLORE FMR)	Sponsor Name Polares Medical SA	NCT Number NCT04666467	IDE Number G200063	CMS Approval Date 2021-04-16	Category A
Study Title Early Feasibility EXperience of Posterior Leaflet RestOration to REduce Degenerative Mitral Regurgitation (EXPLORE DMR)	Sponsor Name Polares Medical SA	NCT Number NCT04666480	IDE Number G200063	CMS Approval Date 2021-04-16	Category A
Study Title Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms With Physician-Modified Fenestrated and Branched Stent Grafts	Sponsor Name University of Southern California	NCT Number NCT04524247	IDE Number G200159	CMS Approval Date 2021-04-16	Category B
Study Title B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair	Sponsor Name Eric Roselli, M. D.	NCT Number NCT04747626	IDE Number G200342	CMS Approval Date 2021-04-16	Category B
Study Title An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients With Cardiorenal Syndrome	Sponsor Name Procyrion	NCT Number NCT04145635	IDE Number G200294	CMS Approval Date 2021-04-09	Category B
Study Title Safety and Effectiveness Study of the AngioSafe Peripheral CTO Crossing System	Sponsor Name AngioSafe, Inc.	NCT Number NCT04663867	IDE Number G200271	CMS Approval Date 2021-04-09	Category B
Study Title Clinical Outcomes, Radiation Dosage, and Quality of Life in Patients Treated With Fenestrated Stent Grafts for Complex Thoracoabdominal and Abdominal Aortic Aneurysms, Thoracoabdominal Aortic Aneurysms Secondary to Aortic Dissections	Sponsor Name Medstar Health Research Institute	NCT Number NCT04526938	IDE Number G190192	CMS Approval Date 2021-04-09	Category B
Study Title A Randomized, Multi-Center, Prospective, Safety and Efficacy Study Comparing the Outcome of Total Reverse Shoulder Arthroplasty (RSA) With SMR Stemless Reverse vs SMR Reverse Shoulder System	Sponsor Name Limacorporate S.p.a	NCT Number NCT04697004	IDE Number G200295	CMS Approval Date 2021-04-01	Category B
Study Title Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip: The V-Wave Shunt MitraClip Study	Sponsor Name The Cleveland Clinic	NCT Number NCT04729933	IDE Number G200329	CMS Approval Date 2021-04-01	Category B
Study Title A Study to Document the Safety and Effectiveness of a New Cohesive OVD When Compared to a Control OVD	Sponsor Name Precision for Medicine	NCT Number NCT04192630	IDE Number G190194	CMS Approval Date 2021-03-26	Category B
Study Title Prospective, Multicenter, Non-randomized Study With Consecutive, Eligible Subject Enrollment at Each Site, for the Evaluation of the ChEVAS System for Endovascular Repair of Paravisceral, Juxtarenal, and Pararenal Abdominal Aortic Aneurysms	Sponsor Name Endologix	NCT Number NCT04252573	IDE Number G130005	CMS Approval Date 2021-03-26	Category B
Study Title Prospective, randomized, controlled, multicenter, clinical investigation evaluation the safety of HEMOBLAST™ BELLOWS in spine surgery	Sponsor Name Dilon Technologies	NCT Number NCT04734535	IDE Number G200210	CMS Approval Date 2021-03-26	Category B
Study Title A Study to Evaluate the Feasibility and Safety of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation: (Millipede Feasibility Study)	Sponsor Name Boston Scientific Corporation	NCT Number NCT04147884	IDE Number G200335	CMS Approval Date 2021-03-26	Category A
Study Title Safety and Effectiveness of Bio2 Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion. A Randomized, Controlled, Non-inferiority, Pivotal Study	Sponsor Name Bio2 Technologies	NCT Number NCT03828136	IDE Number G180054	CMS Approval Date 2021-03-26	Category A
Study Title Left Atrial Posterior Wall Isolation in Conjunction With Pulmonary Vein Isolation Using the Cryoballoon for Treatment of Persistent Atrial Fibrillation (PIVoTAL) - IDE Trial	Sponsor Name Dignity Health Medical Foundation	NCT Number NCT04505163	IDE Number G190171	CMS Approval Date 2021-03-04	Category B
Study Title A Prospective Randomized Pivotal Trial of the FARAPULSE Pulsed Field Ablation System Compared With Standard of Care Ablation in Patients With Paroxysmal Atrial Fibrillation	Sponsor Name FARAPULSE, INC.	NCT Number NCT04612244	IDE Number G200259	CMS Approval Date 2021-03-04	Category B
Study Title A Prospective, Multicenter, Non-randomized, Single-arm, Open-label Clinical Study to Demonstrate the Safety and Performance of the Leaflex™ Performer	Sponsor Name Pi-cardia	NCT Number NCT04636073	IDE Number G200144	CMS Approval Date 2021-03-04	Category A
Study Title The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER)	Sponsor Name HistoSonics, Inc.	NCT Number NCT04573881	IDE Number G200253	CMS Approval Date 2021-03-04	Category B
Study Title A Prospective, Multicenter, Randomized, Active-Controlled Clinical Study to Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction	Sponsor Name Bausch & Lomb Incorporated	NCT Number NCT03603600	IDE Number G180015	CMS Approval Date 2021-03-04	Category B
Study Title AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)	Sponsor Name Emerson Consultants, Inc.	NCT Number NCT04658940	IDE Number G200143	CMS Approval Date 2021-02-25	Category B
Study Title URIPRENE: Clinical Study to Evaluate the Safety and Device Performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy	Sponsor Name Adva-Tec	NCT Number NCT04565795	IDE Number G200057	CMS Approval Date 2021-02-25	Category B
Study Title Liquid Embolization of Arterial Hemorrhages in the Peripheral Vasculature: The LAVA Study	Sponsor Name BlackSwan Vascular, Inc.	NCT Number NCT04649255	IDE Number G190291	CMS Approval Date 2021-02-25	Category B
Study Title Clinical Utility of Residual Hearing in the Cochlear Implant Ear	Sponsor Name Ohio State University	NCT Number NCT04707885	IDE Number G200266	CMS Approval Date 2021-02-19	Category B
Study Title A Prospective, Multi-Center Investigation of the da Vinci SP® Surgical System in Colorectal Procedures for Benign and Malignant Disease	Sponsor Name Intuitive Surgical	NCT Number NCT04403022	IDE Number G200060	CMS Approval Date 2021-02-18	Category B
Study Title Prospective, Randomized, Controlled, Multicenter Study Comparing the Merit WRAPSODY™ Endovascular Stent Graft to Percutaneous Transluminal Angioplasty for Treatment of Venous Outflow Circuit Stenosis or Occlusion in Hemodialysis Patients. The WAVE Study	Sponsor Name Merit Medical Systems, Inc.	NCT Number NCT04540302	IDE Number G200150	CMS Approval Date 2021-02-18	Category B
Study Title The Safety and Effectiveness of DuraSorb® for Reinforcement in Patients Undergoing Prosthetic Breast Reconstruction	Sponsor Name Surgical Innovation Associates, Inc.	NCT Number NCT04646057	IDE Number G200080	CMS Approval Date 2021-02-11	Category A
Study Title Evaluation of the Safety and Efficacy of the Carag Bioresorbable Septal Occluder (CBSO) to Treat Patients With Clinically Significant Secundum Atrial Septal Defect	Sponsor Name Carag AG	NCT Number NCT04591392	IDE Number G170213	CMS Approval Date 2021-02-11	Category B
Study Title Evaluation of Applaud Medical's Acoustic Enhancer With Laser Lithotripsy System in the Treatment of Urinary Stones	Sponsor Name Applaud Medical, Inc.	NCT Number NCT04563039	IDE Number G200183	CMS Approval Date 2021-02-11	Category B
Study Title Combined Infusion System to Deliver Chemotherapy Regionally to the Liver	Sponsor Name Ronald DeMatteo, M.D.	NCT Number NCT04684862	IDE Number G200283	CMS Approval Date 2021-02-04	Category B
Study Title A Randomized, Open Label, Cross-over Feasibility Study for Heparin-free Hemodialysis With the Dialyzer With Endexo™ in End-Stage Renal Disease (ESRD) Subjects	Sponsor Name Fresenius Medical Care North America	NCT Number NCT04511338	IDE Number G200147	CMS Approval Date 2021-02-04	Category B
Study Title Multicenter Randomized Assessment of the Firehawk™ Rapamycin TARGET Eluting Cobalt Chromium Coronary Stent System - North American Trial	Sponsor Name MicroPort	NCT Number NCT04562532	IDE Number G170070	CMS Approval Date 2021-01-28	Category B
Study Title A Pilot Protocol Evaluating Safety of the Medtronic Pump and Codman Catheter for the Delivery of Hepatic Arterial Infusion (HAI) Chemotherapy in Patients With Advanced Colorectal Carcinoma or Cholangiocarcinoma	Sponsor Name Benaroya Research Institute	NCT Number NCT04668976	IDE Number G190296	CMS Approval Date 2021-01-28	Category B
Study Title IMPact on Revascularization Outcomes of intraVascular Ultrasound Guided Treatment of Complex Lesions and Economic Impact (IMPROVE)	Sponsor Name Medstar Health Research Institute	NCT Number NCT04221815	IDE Number G190299	CMS Approval Date 2021-01-22	Category B
Study Title Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation	Sponsor Name Boston Scientific Corporation	NCT Number NCT04580914	IDE Number G200215	CMS Approval Date 2021-01-22	Category B
Study Title Prospective, Open-Label, Multi-Center Single-Arm Trial Designed to Assess the Safety, Performance and Efficacy of the NeVa Stent Retriever in the Treatment of Large Vessel Occlusion Strokes	Sponsor Name Vesalio	NCT Number NCT04514562	IDE Number G170281	CMS Approval Date 2021-01-22	Category B
Study Title The DETOUR2 Continued Access Clinical Trial - The Detour Endovascular Technique for Long OcclUsive Fem-pop Revascularization - Continued Access Clinical Trial	Sponsor Name PQ Bypass, Inc.	NCT Number NCT04625660	IDE Number G170083	CMS Approval Date 2021-01-22	Category B
Study Title Early Feasibility Study for the Foldax Tria Aortic Heart Valve	Sponsor Name Foldax, Inc	NCT Number NCT03851068	IDE Number G180106	CMS Approval Date 2021-01-15	Category A
Study Title Randomized Multi-Center, Subject and Evaluator Blinded, Parallel-Group Study to Evaluate the Safety and Effectiveness of the Instylla Hydrogel Embolic System (HES) Compared With Standard of Care Transcatheter Arterial Embolization (TAE) / Transcatheter Ar...	Sponsor Name Instylla, Inc.	NCT Number NCT04523350	IDE Number G200149	CMS Approval Date 2021-01-15	Category B
Study Title PARADIGM PARAvalvular Leak Closure With the Amplatzer Valvular Plug occluDer for Interventional Transcatheter Closure for PVL With Surgical bioloGical and Mechanical Heart Valve	Sponsor Name Abbott Medical Devices	NCT Number NCT04489823	IDE Number G200097	CMS Approval Date 2021-01-15	Category B
Study Title Esophagus Deviation and Radiofrequency Ablation of Atrial Fibrillation - EASY AF STUDY	Sponsor Name S4 Medical	NCT Number NCT04659213	IDE Number G200064	CMS Approval Date 2021-01-15	Category B
Study Title A Study to Evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure	Sponsor Name Corvia Medical	NCT Number NCT04632160	IDE Number G150210	CMS Approval Date 2021-01-15	Category B
Study Title The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)	Sponsor Name TransMedics	NCT Number NCT04615182	IDE Number G180272	CMS Approval Date 2021-01-14	Category B
Study Title ENRAPTUS Epicardial Mitral Touch System for Mitral Insufficiency	Sponsor Name Mitre Medical Corp.	NCT Number NCT04396379	IDE Number G190043	CMS Approval Date 2021-01-08	Category A
Study Title STITCH - Prospective Multi Center Comparative Parallel Concurrent Study of the NobleStitch EL Compared to FDA Approved Amplatzer Occluder Device for Closure of Patent Foramen Ovale to Prevent Recurrent Ischemic Stroke	Sponsor Name HeartStitch.Com	NCT Number NCT04339699	IDE Number G180296	CMS Approval Date 2021-01-08	Category B
Study Title Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF	Sponsor Name Medtronic Cardiac Rhythm and Heart Failure	NCT Number NCT04198701	IDE Number G190272	CMS Approval Date 2021-01-08	Category B
Study Title Senza Spinal Cord Stimulation (SCS) System	Sponsor Name NEVRO	NCT Number NCT04630106	IDE Number G180132	CMS Approval Date 2020-12-21	Category B
Study Title The Safety and Effectiveness of the SAPIEN 3 and SAPIEN 3 Ultra Valve in Patients With Symptomatic Severe Calcific Mitral Valve Disease With Severe Mitral Annular Calcification Who Are Not Candidates for Standard Mitral Valve Surgery.	Sponsor Name Mayra Guerrero	NCT Number NCT04408430	IDE Number G200074	CMS Approval Date 2020-12-10	Category B
Study Title ENDOVASCULAR ABLATION OF THE RIGHT GREATER SPLANCHNIC NERVE IN Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF: Feasibility Study: Randomized Controlled Feasibility Trial- Rebalance HF Study	Sponsor Name Axon Therapies, Inc.	NCT Number NCT04592445	IDE Number G200219	CMS Approval Date 2020-12-10	Category B
Study Title Agent Monorail Paclitaxel-Coated PTCA Balloon Catheter	Sponsor Name Boston Scientific Corporation	NCT Number NCT04647253	IDE Number G200100	CMS Approval Date 2020-12-10	Category B
Study Title A Prospective, Single-Center, Non-Randomized, Clinical Trial of Transplantation of Discarded Livers Using Normothermic Machine Perfusion (NMP)	Sponsor Name Washington University School of Medicine	NCT Number NCT04483102	IDE Number G200163	CMS Approval Date 2020-12-03	Category B
Study Title A Prospective, Randomized, Double-Blind, Sham-Controlled, Multi-Center Pivotal Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes on Insulin Therapy	Sponsor Name Fractyl Laboratories, Inc.	NCT Number NCT04419779	IDE Number G160104	CMS Approval Date 2020-12-03	Category A
Study Title Non-Randomized, Multi-Site, Single-Arm Study of the LinguaFlex™ Tongue Retractor (LTR) for the Treatment of Moderate to Severe Obstructive Sleep Apnea and Snoring in Adult Subjects	Sponsor Name Linguaflex, Inc.	NCT Number NCT04129229	IDE Number G190178	CMS Approval Date 2020-11-20	Category B
Study Title Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device	Sponsor Name Edwards Lifesciences	NCT Number NCT04482062	IDE Number G190289	CMS Approval Date 2020-11-19	Category B
Study Title Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation in Patients With Pulmonary Arterial Hypertension	Sponsor Name SoniVie Inc.	NCT Number NCT04570228	IDE Number G160110	CMS Approval Date 2020-11-19	Category B
Study Title Embotrap eXtraction & Clot EvaLuation & Lesion Evaluation for NeuroThrombectomy	Sponsor Name Neuravi Limited	NCT Number NCT03685578	IDE Number G200053	CMS Approval Date 2020-11-19	Category B
Study Title Immunotherapy Combined With Yttrium-90 RadioEmbolization in the Treatment of Colorectal Cancer With Liver Metastases [iRE-C - Clinical Trial]	Sponsor Name University of Iowa	NCT Number NCT04108481	IDE Number G200069	CMS Approval Date 2020-11-19	Category B
Study Title A Multicenter, Prospective, Randomized, Clinical Trial Comparing the Safety and Effectiveness of the BAGUERA®C Cervical Disc Prosthesis to the Mobi-C® Cervical Disc for the Treatment of Patients With Symptomatic Cervical Disc Disease at Two Contiguous L...	Sponsor Name Spineart USA	NCT Number NCT04564885	IDE Number G200239	CMS Approval Date 2020-11-12	Category B
Study Title Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study	Sponsor Name Ancora Heart, Inc.	NCT Number NCT04331769	IDE Number G150249	CMS Approval Date 2020-11-12	Category B
Study Title Genicular Artery Embolization for the Treatment of Moderate to Severe Osteoarthritic Knee Pain	Sponsor Name Andrew Picel	NCT Number NCT04472091	IDE Number G200111	CMS Approval Date 2020-11-06	Category B
Study Title Functional Electrical Stimulation of the Bilaterally Paralyzed Human Larynx	Sponsor Name Vanderbilt University Medical Center	NCT Number NCT04028674	IDE Number G140049	CMS Approval Date 2020-11-06	Category B
Study Title A Multicenter Study to Assess the Safety and Effectiveness of the Genio Dual-sided Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnea in Adults Subjects	Sponsor Name Nyxoah S.A.	NCT Number NCT03868618	IDE Number G190068	CMS Approval Date 2020-11-06	Category B
Study Title The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)	Sponsor Name Balt USA	NCT Number NCT04410146	IDE Number G190038	CMS Approval Date 2020-10-30	Category B
Study Title A Multicenter, Prospective, Randomized, Clinical Trial Comparing the Safety and Effectiveness of the BAGUERA®C Cervical Disc Prosthesis to the Mobi-C® Cervical Disc for the Treatment of Patients With Symptomatic Cervical Disc Disease at a Single Level	Sponsor Name Spineart USA	NCT Number NCT04520776	IDE Number G200182	CMS Approval Date 2020-10-30	Category B
Study Title Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System	Sponsor Name Vesper Medical, Inc.	NCT Number NCT04580160	IDE Number G190030	CMS Approval Date 2020-10-30	Category B
Study Title A Multi-arm, Multi-Center, Non-Randomized, Prospective, Clinical Study to Evaluate the Safety and Effectiveness of the NEXUS Aortic Arch Stent Graft System in Treating Thoracic Aortic Lesions Involving the Aortic Arch	Sponsor Name Endospan Ltd.	NCT Number NCT04471909	IDE Number G200105	CMS Approval Date 2020-10-30	Category B
Study Title Physiologic Accelerated Pacing as a Treatment in Patients With Heart Failure With Preserved Ejection Fraction	Sponsor Name Medtronic	NCT Number NCT04546555	IDE Number G200158	CMS Approval Date 2020-10-22	Category B
Study Title Prospective Pilot Study of Robot-Assisted Nipple Sparing Mastectomy (RNSM)	Sponsor Name Ko Un Park	NCT Number NCT04537312	IDE Number G200096	CMS Approval Date 2020-10-22	Category A
Study Title Randomized Prospective Trial of Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer	Sponsor Name CairnSurgical, Inc.	NCT Number NCT04397185	IDE Number G190266	CMS Approval Date 2020-10-15	Category A
Study Title Safety and Effectiveness Evaluation of Boston Scientific's Single Shot LUMINIZE RF Balloon Catheter in the Treatment of Symptomatic, Drug Refractory Paroxysmal Atrial Fibrillation	Sponsor Name Boston Scientific Corporation	NCT Number NCT03852420	IDE Number G200008	CMS Approval Date 2020-10-15	Category B
Study Title Non-randomized, Multicenter Expanded Use Evaluation of the LARIAT® Suture Delivery Device (Appendix 16 to Ongoing Investigation)	Sponsor Name AtriCure, Inc.	NCT Number NCT04468334	IDE Number G150107	CMS Approval Date 2020-10-08	Category B
Study Title A Multi-Center, Prospective, Historically Controlled Pivotal Trial Comparing The Safety And Effectiveness Of The Synergy Disc To Anterior Cervical Discectomy And Fusion In Patients With One-Level Symptomatic Cervical Degenerative Disc Disease (DDD).	Sponsor Name Synergy Disc Replacement Ltd	NCT Number NCT04469231	IDE Number G180090	CMS Approval Date 2020-10-08	Category B
Study Title A Pilot Study of Endoscope-assisted, Minimally-invasive Cortical Access System (MICAS) for Chronic Subdural Evacuation	Sponsor Name Mayo Clinic	NCT Number NCT04502745	IDE Number G200104	CMS Approval Date 2020-10-08	Category B
Study Title A Prospective, Multi-Center, Single Arm Study to Evaluate the Q Revascularization System for Neurointervention in Acute Ischemic Stroke: The EvaQ Study	Sponsor Name MIVI Neuroscience, Inc.	NCT Number NCT04437862	IDE Number G200124	CMS Approval Date 2020-10-01	Category B
Study Title Pilot Trial of NovoTTF -200A (TTFields) in Patients With Newly Diagnosed High Risk Oligodendrogliomas	Sponsor Name University of Southern California	NCT Number NCT03353896	IDE Number G170079	CMS Approval Date 2020-10-01	Category B
Study Title A Phase II Study of Induction Systemic mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone Given Concurrently With Systemic mFOLFIRI as a First-Line Therapy in Patients With Unresectable Liver-Dominant Intrahepatic Cholangio...	Sponsor Name OHSU Knight Cancer Institute	NCT Number NCT04251715	IDE Number G190104	CMS Approval Date 2020-10-01	Category B
Study Title EF-32: Pivotal, Randomized, Open-Label Study of Optune® (Tumor Treating Fields, 200kHz) Concomitant With Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma	Sponsor Name NovoCure GmbH	NCT Number NCT04471844	IDE Number G200113	CMS Approval Date 2020-10-01	Category B
Study Title Feasibility and Safety of Geniculate Artery Embolization for Treatment of Mild to Moderate Knee Osteoarthritis	Sponsor Name NYU Langone Health	NCT Number NCT04379700	IDE Number G190316	CMS Approval Date 2020-09-09	Category B
Study Title An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System	Sponsor Name HighLife SAS	NCT Number NCT04029337	IDE Number G180244	CMS Approval Date 2020-09-09	Category A
Study Title A Study of the Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System In the Treatment of Subacute and Chronic Subdural HEmatoma (EMBOLISE)	Sponsor Name Medtronic Neurovascular Clinical Affairs	NCT Number NCT04402632	IDE Number G190263	CMS Approval Date 2020-09-02	Category B
Study Title Prophylactic Tumor Treating Fields in Management of Patients With Small Cell Lung Cancer	Sponsor Name OHSU Knight Cancer Institute	NCT Number NCT03995667	IDE Number G180232	CMS Approval Date 2020-09-02	Category A
Study Title Harpoon Beating Mitral Valve Repair System	Sponsor Name Edwards Lifesciences	NCT Number NCT04375332	IDE Number G200067	CMS Approval Date 2020-09-02	Category B
Study Title EUS-guided Gastroenterostomy Versus Enteral Stenting for Palliation of Malignant Gastric Outlet Obstruction: A Randomized Clinical Trial	Sponsor Name Johns Hopkins University	NCT Number NCT03259763	IDE Number G190156	CMS Approval Date 2020-08-07	Category B
Study Title Safety and Effectiveness of TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex SE) for the Treatment of Drug Refractory, Symptomatic, Paroxysmal Atrial Fibrillation	Sponsor Name Abbott Medical Devices	NCT Number NCT04356040	IDE Number G190293	CMS Approval Date 2020-08-07	Category B
Study Title A Prospective, Multicenter Investigation of the da Vinci® Xi™ Surgical System in Nipple Sparing Mastectomy (NSM) Procedures	Sponsor Name Intuitive Surgical	NCT Number NCT03892980	IDE Number G190065	CMS Approval Date 2020-07-31	Category A
Study Title CAPERE Embolectomy System	Sponsor Name Vascular Medcure, Inc.	NCT Number NCT04409158	IDE Number G200036	CMS Approval Date 2020-07-23	Category B
Study Title An Open Label Study to HemoCare™ Hemodialysis System for Home Hemodialysis Prior to Market Authorization	Sponsor Name Deka Research and Development	NCT Number NCT04198012	IDE Number G090207	CMS Approval Date 2020-07-23	Category B
Study Title EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms Not Amenable To Clipping And coilinG With the Pipeline™ Vantage Embolization Device (VANTAGE)	Sponsor Name Medtronic Neurovascular Clinical Affairs	NCT Number NCT04391803	IDE Number G190319	CMS Approval Date 2020-06-11	Category B
Study Title Evoke Spinal Cord Stimulator System	Sponsor Name saluda MEDICAL	NCT Number NCT04319887	IDE Number G150266	CMS Approval Date 2020-06-11	Category B
Study Title A Clinical Investigation to Assess the Abbott Next Generation Drug Eluting Stent 48mm Everolimus Eluting Coronary Stent System (EECSS) in Treatment of de Novo Native Coronary Artery Disease	Sponsor Name Abbott Medical Devices	NCT Number NCT04282148	IDE Number G200002	CMS Approval Date 2020-06-11	Category B
Study Title A Single-Arm Study to Assess the Safety and Efficacy of the SoundBite™ Crossing System With ACTIVE Wire in Coronary Chronic Total Occlusions (the ACTIVE Trial).	Sponsor Name SoundBite Medical Solutions, Inc.	NCT Number NCT03521804	IDE Number G180212	CMS Approval Date 2020-06-11	Category B
Study Title Dual Lead Thalamic DBR-DBS Interface for Closed Loop Control of Severe Essential Tremor	Sponsor Name University of Florida	NCT Number NCT04212780	IDE Number G190246	CMS Approval Date 2020-05-14	Category B
Study Title Carmat Total Artificial Heart Early Feasibility Study	Sponsor Name Carmat SA	NCT Number NCT04117295	IDE Number G180184	CMS Approval Date 2020-05-07	Category B
Study Title Protection Against Emboli During Carotid Artery Stenting Using a 3-in-1 Delivery System Comprised of a Post-dilation Balloon, Integrated Embolic Filter and a Novel Carotid Stent II	Sponsor Name Contego Medical, LLC	NCT Number NCT04201132	IDE Number G200007	CMS Approval Date 2020-04-30	Category B
Study Title Randomized Trial of Barrigel® to increase distance between the prostate and rectum to decrease rectal dose in patients receiving definitive radiation therapy for localized prostate cancer	Sponsor Name Palette Life Sciences	NCT Number NCT04189913	IDE Number G190206	CMS Approval Date 2020-04-23	Category B
Study Title STEMI Cool Pilot Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention In Patients With Acute Myocardial Infarction (Phase A)	Sponsor Name ZOLL Circulation, Inc., USA	NCT Number NCT03361995	IDE Number G170080	CMS Approval Date 2020-04-23	Category B
Study Title A Clinical Investigation of the Adjustable Continence Therapy (ACT) for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency	Sponsor Name Uromedica	NCT Number NCT04248283	IDE Number G190277	CMS Approval Date 2020-04-15	Category B
Study Title CG- 100 Intraluminal ByPass Device	Sponsor Name Colospan	NCT Number NCT04184973	IDE Number G190167	CMS Approval Date 2020-04-15	Category A
Study Title A Study of MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue	Sponsor Name Nanospectra Biosciences, Inc.	NCT Number NCT04240639	IDE Number G150081	CMS Approval Date 2020-04-03	Category A
Study Title A Multicenter, Randomized, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment With the Nuvaira™ Lung Denervation System in Patients With Chronic Obstructive Pulmonary Disease (COPD)	Sponsor Name Nuvaira, Inc.	NCT Number NCT03639051	IDE Number G180199	CMS Approval Date 2020-04-02	Category B
Study Title Recombinant tPA by Endovascular Administration for the treatment of Submassive pulmonary embolism using pharmaco-mechanical Catheter directed thrombolysis for the redUction of thrombus burdEn - The RESCUE Study	Sponsor Name Thrombolex, Inc.	NCT Number NCT04248868	IDE Number G200009	CMS Approval Date 2020-04-02	Category B
Study Title GORE PV1 Device	Sponsor Name Gore	NCT Number NCT03441971	IDE Number G170289	CMS Approval Date 2020-04-02	Category B
Study Title LIFE-BTK (pivotaL Investigation of saFety and Efficacy of BRS Treatment-Below The Knee) Randomized Controlled Trial	Sponsor Name Abbott Medical Devices	NCT Number NCT04227899	IDE Number G190111	CMS Approval Date 2020-03-26	Category B
Study Title A Study of the Pipeline™ Vantage Embolization Device With Shield Technology™ for Endovascular Treatment of Wide-Necked Intracranial Aneurysms	Sponsor Name Medtronic Neurovascular Clinical Affairs	NCT Number NCT03873714	IDE Number G170234	CMS Approval Date 2020-03-26	Category B
Study Title Early Feasibility Study of Fetoscopic Myelomeningocele Repair Using a Cryopreserved Human Umbilical Cord Allograft (NEOX Cord 1K®) as a Meningeal Patch	Sponsor Name The University of Texas Health Science Center, Houston	NCT Number NCT04243889	IDE Number G190253	CMS Approval Date 2020-03-19	Category A
Study Title A Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages	Sponsor Name Ra Medical Systems	NCT Number NCT04241224	IDE Number G190119	CMS Approval Date 2020-03-19	Category B
Study Title Feasibility of Auditory Nerve Test System for Optimization of Simultaneous Translabyrinthine Vestibular Schwannoma Resection With Cochlear Implantation	Sponsor Name Washington University School of Medicine	NCT Number NCT04241679	IDE Number G190197	CMS Approval Date 2020-03-12	Category B
Study Title Intrepid Transcatheter Mitral Valve Replacement System	Sponsor Name Medtronic	NCT Number NCT02322840	IDE Number G160020	CMS Approval Date 2020-03-12	Category B
Study Title EndoVascular Treatment Of Wide-Neck Aneurysms, an EvaLuation of Safety and EffectiVeness of Stryker Surpass Evolve™ Flow Diverter System	Sponsor Name Stryker Neurovascular	NCT Number NCT04195568	IDE Number G190084	CMS Approval Date 2020-03-05	Category B
Study Title ENGOT-ov50 / GOG-3029 / INNOVATE-3: Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 200kHz) Concomitant With Weekly Paclitaxel for the Treatment of Recurrent Ovarian Cancer	Sponsor Name NovoCure Ltd.	NCT Number NCT03940196	IDE Number G190254	CMS Approval Date 2020-03-05	Category B
Study Title Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation: A Pilot Study	Sponsor Name Vivek Reddy	NCT Number NCT04182620	IDE Number G190234	CMS Approval Date 2020-03-05	Category B
Study Title Superior Vena Caval Occlusion in Subjects With Acute Decompensated Heart Failure	Sponsor Name preCARDIA Inc	NCT Number NCT03836079	IDE Number G180213	CMS Approval Date 2020-03-05	Category B
Study Title A Sham Controlled Prospective Randomized Clinical Trial of the RejuvenAir® System for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease With Chronic Bronchitis	Sponsor Name CSA Medical, Inc.	NCT Number NCT03893370	IDE Number G190039	CMS Approval Date 2020-02-27	Category A
Study Title Prospective, Randomized, Controlled, Blinded Pivotal Study In Subjects Undergoing A Transforaminal Lumbar Interbody Fusion (TLIF) At One Or Two Levels Using Infuse™ Bone Graft and The Capstone™ Spinal System With Posterior Supplemental Fixation For Th...	Sponsor Name Medtronic Spinal and Biologics	NCT Number NCT04073563	IDE Number G180160	CMS Approval Date 2020-02-27	Category B
Study Title Safety and Efficacy of the Slit Stent II Lacrimal Stent for the Treatment of Nasolacrimal Duct Obstruction	Sponsor Name Alon Kahana	NCT Number NCT03705000	IDE Number G180070	CMS Approval Date 2020-02-27	Category B
Study Title Combined Cortical and Subcortical Recording and Stimulation as a Circuit-Oriented Treatment for Obsessive-Compulsive Disorder	Sponsor Name Massachusetts General Hospital	NCT Number NCT03184454	IDE Number G160009	CMS Approval Date 2020-02-27	Category B
Study Title EVOQUE TR EFS	Sponsor Name Edwards Lifesciences	NCT Number NCT04221490	IDE Number G190289	CMS Approval Date 2020-02-19	Category A
Study Title A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With an Acute, Complicated Type B Aortic Dissection	Sponsor Name Bolton Medical	NCT Number NCT03033043	IDE Number G040175	CMS Approval Date 2020-02-19	Category B
Study Title Continued Access Protocol To Evaluate the Effectiveness of the Portable Organ Care System (OCS) Liver for Preserving and Assessing Donor Livers for Transplantation	Sponsor Name TransMedics	NCT Number NCT04186221	IDE Number G140192	CMS Approval Date 2020-02-12	Category B
Study Title Chronic Total Occlusion Percutaneous Coronary Intervention CTO-PCI Study	Sponsor Name Vascular Solutions, Inc	NCT Number NCT03988166	IDE Number G190013	CMS Approval Date 2020-02-06	Category B
Study Title A Prospective, Multicenter, Double Blind, Randomized, Clinical Study to Evaluate the Safety and Efficacy of the Optilume™ BPH Catheter System in Men With Symptomatic BPH	Sponsor Name Urotronic Inc.	NCT Number NCT04131907	IDE Number G190217	CMS Approval Date 2020-02-05	Category B
Study Title Zip-stitch Vaginal Cuff Closure System	Sponsor Name ZSX Medical, LLC.	NCT Number NCT04081727	IDE Number G190106	CMS Approval Date 2020-02-05	Category B
Study Title Safety and Effectiveness of Posterior Cervical Stabilization System (PCSS) as an Adjunct to Posterior Cervical Fusion, When Used in Combination With ACDF in Treatment of Multi-level Cervical Degenerative Disease	Sponsor Name Providence Medical Technology, Inc.	NCT Number NCT04229017	IDE Number G190235	CMS Approval Date 2020-01-30	Category B
Study Title The Citadel Embolization Device Feasibility Study	Sponsor Name Stryker Neurovascular	NCT Number NCT04057352	IDE Number G190087	CMS Approval Date 2020-01-30	Category B
Study Title Endovascular Therapy for Low NIHSS Ischemic Strokes	Sponsor Name Emory University	NCT Number NCT04167527	IDE Number G190069	CMS Approval Date 2020-01-30	Category B
Study Title Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression	Sponsor Name University of California, Los Angeles	NCT Number NCT03952962	IDE Number G180179	CMS Approval Date 2020-01-29	Category B
Study Title Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain Using Summit RC+S	Sponsor Name University of California, San Francisco	NCT Number NCT04144972	IDE Number G190160	CMS Approval Date 2020-01-15	Category B
Study Title Magnetic Seizure Therapy In Bipolar Depression (MST-BpD)	Sponsor Name The University of Texas Health Science Center, Houston	NCT Number NCT04080778	IDE Number G190133	CMS Approval Date 2020-01-15	Category B
Study Title Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study	Sponsor Name Abbott Medical Devices	NCT Number NCT04069156	IDE Number G190147-1	CMS Approval Date 2020-01-15	Category B
Study Title Safety and Effectiveness IDE Trial for Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation	Sponsor Name Boston Scientific Corporation	NCT Number NCT04133168	IDE Number G190060	CMS Approval Date 2019-12-31	Category B
Study Title ASSURE WCD Clinical Evaluation - Conversion Efficacy Study (ACE-CONVERT)	Sponsor Name Kestra Medical Technologies, Inc.	NCT Number NCT04132466	IDE Number G190232	CMS Approval Date 2019-12-31	Category B
Study Title NuPulseCV-iVAS	Sponsor Name NuPulseCV, Inc.	NCT Number NCT04065659	IDE Number G150242	CMS Approval Date 2019-12-27	Category B
Study Title A Prospective, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of PMX Cartridge in Addition to Standard Medical Care for Patients With Endotoxemic Septic Shock	Sponsor Name Spectral Diagnostics (US) Inc.	NCT Number NCT03901807	IDE Number G090151	CMS Approval Date 2019-12-27	Category B
Study Title Clinical Evaluation of the HemoCare™ Hemodialysis System for Home Nocturnal Hemodialysis	Sponsor Name Deka Research and Development	NCT Number NCT04087213	IDE Number G090207	CMS Approval Date 2019-12-19	Category B
Study Title A Multicenter, Prospective, Randomized-controlled Trial to Assess the Safety and Feasibility of Cooling as an Adjunctive Therapy to Thrombectomy and Reperfusion in Patients With Acute Cerebral Ischemia and Stroke	Sponsor Name ZOLL Circulation, Inc., USA	NCT Number NCT03804060	IDE Number G170246	CMS Approval Date 2019-12-18	Category B
Study Title ZOOM Reperfusion Catheters	Sponsor Name Imperative Care, Inc.	NCT Number NCT04129125	IDE Number G190058	CMS Approval Date 2019-12-18	Category B
Study Title Prospective, Multicenter Study Evaluating the Performance and Safety of FRAME, External Support for Lower Limb Autologous Grafts	Sponsor Name Vascular Graft Solutions Ltd.	NCT Number NCT04003480	IDE Number G180234	CMS Approval Date 2019-12-18	Category A
Study Title SAPIEN M3 System	Sponsor Name Edwards Lifesciences	NCT Number NCT04153292	IDE Number G170152	CMS Approval Date 2019-12-18	Category B
Study Title The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study for Occlusive and Re-stenotic Fem-pop Revascularization - 2 Trial: TORUS 2	Sponsor Name PQ Bypass, Inc.	NCT Number NCT04130737	IDE Number G190226	CMS Approval Date 2019-12-17	Category B
Study Title A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of the RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction	Sponsor Name Avita Medical	NCT Number NCT04091672	IDE Number BB13053	CMS Approval Date 2019-12-04	Category B
Study Title Study of the Safety and Effectiveness of the Motiva Implants® Silicone Gel-Filled Breast Implants SmoothSilk®/SilkSurface® in Subjects Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, and Revision Surgery	Sponsor Name Motiva USA LLC	NCT Number NCT03579901	IDE Number G170186	CMS Approval Date 2019-12-04	Category A
Study Title Extravascular ICD Pivotal Study (EV ICD)	Sponsor Name Medtronic Cardiac Rhythm and Heart Failure	NCT Number NCT04060680	IDE Number G190186	CMS Approval Date 2019-12-04	Category B
Study Title Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: the PROMISE II Trial	Sponsor Name LimFlow, Inc.	NCT Number NCT03970538	IDE Number G160156	CMS Approval Date 2019-12-04	Category B
Study Title pRESET for Occlusive Stroke Treatment	Sponsor Name phenox Inc.	NCT Number NCT03994822	IDE Number G190099	CMS Approval Date 2019-12-04	Category B
Study Title A Prospective, Multi-Center, Randomized, Controlled, Single Blind Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class III Heart Failure Patients	Sponsor Name Endotronix, Inc.	NCT Number NCT04089059	IDE Number G190020	CMS Approval Date 2019-10-30	Category B
Study Title iCLAS™ for Persistent Atrial Fibrillation	Sponsor Name Adagio Medical	NCT Number NCT04061603	IDE Number G180263	CMS Approval Date 2019-10-30	Category B
Study Title Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory	Sponsor Name West Virginia University	NCT Number NCT03950492	IDE Number G190011	CMS Approval Date 2019-10-30	Category B
Study Title A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT A...	Sponsor Name Edwards Lifesciences	NCT Number NCT04097145	IDE Number G180266	CMS Approval Date 2019-10-30	Category B
Study Title Alfapump® System in the Treatment of Refractory or Recurrent Ascites: a Multicenter Single Arm Within Subject Crossover Design Pivotal Study (the POSEIDON Study)	Sponsor Name Sequana Medical N.V.	NCT Number NCT03973866	IDE Number G140126	CMS Approval Date 2019-10-09	Category B
Study Title A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)	Sponsor Name Micro Medical Solution, Inc.	NCT Number NCT04025008	IDE Number G170126	CMS Approval Date 2019-10-02	Category B
Study Title A Multi-Center, Prospective, Randomized Controlled Trial Comparing the Safety and Effectiveness of Prodisc® C SK and Prodisc® C Vivo to Mobi-C® Cervical Disc in the Treatment of Two-Level Symptomatic Cervical Disc Disease (SCDD)	Sponsor Name Centinel Spine	NCT Number NCT04012996	IDE Number G190041	CMS Approval Date 2019-09-19	Category B
Study Title CorMatrix Cor TRICUSPID ECM Valve Replacement Safety and Early Feasibility	Sponsor Name CorMatrix Cardiovascular, Inc.	NCT Number NCT02397668	IDE Number G180240	CMS Approval Date 2019-09-04	Category A
Study Title Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial	Sponsor Name Abiomed Inc.	NCT Number NCT03947619	IDE Number G160197	CMS Approval Date 2019-09-04	Category B
Study Title Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms	Sponsor Name Matthew Eagleton	NCT Number NCT04009512	IDE Number G190023	CMS Approval Date 2019-08-23	Category B
Study Title A Prospective, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Effectiveness of the Episealer® Knee System Compared to Microfracture for the Treatment of Focal Femoral Knee Chondral or Osteochondral Lesions	Sponsor Name Episurf Medical Inc.	NCT Number NCT04000659	IDE Number G180145	CMS Approval Date 2019-08-23	Category B
Study Title Exploring the Effects of Spinal Cord Stimulation in Parkinson's Disease	Sponsor Name Nora Vanegas-Arroyave	NCT Number NCT03526991	IDE Number G180057	CMS Approval Date 2019-08-23	Category B
Study Title AtriCure Synergy Ablation System	Sponsor Name Spectrum Health	NCT Number NCT03604432	IDE Number G170274	CMS Approval Date 2019-08-23	Category A
Study Title A Multi-center, Randomized, Controlled, Single Blinded, Parallel-group Study Evaluating the Clinical Performance and Safety of LiquiBand FIX8® Versus Control for Hernia Mesh Fixation and Peritoneal Closure in Groin Hernia Repair	Sponsor Name Advanced Medical Solutions Ltd.	NCT Number NCT04009213	IDE Number G190018	CMS Approval Date 2019-08-14	Category B
Study Title Edwards Transcatheter Atrial Shunt System	Sponsor Name Edwards Lifesciences	NCT Number NCT03523416	IDE Number G180033	CMS Approval Date 2019-07-31	Category A
Study Title Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal	Sponsor Name Abbott Medical Devices	NCT Number NCT03904147	IDE Number G170118	CMS Approval Date 2019-07-24	Category B
Study Title TECNIS Next-Generation OptiBlue Intraocular Lenses (IOLs) Model ZFR00V	Sponsor Name Johnson & Johnson Surgical Vision, Inc.	NCT Number NCT03949335	IDE Number G190057	CMS Approval Date 2019-07-03	Category B
Study Title Clinical Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death (DCD Heart Trial)	Sponsor Name TransMedics	NCT Number NCT03831048	IDE Number G180272	CMS Approval Date 2019-05-24	Category B
Study Title Phasix Mesh	Sponsor Name Davol, Inc.	NCT Number NCT03911700	IDE Number G180186	CMS Approval Date 2019-05-24	Category A
Study Title The TELSA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke	Sponsor Name Mercy Health Ohio	NCT Number NCT03805308	IDE Number G190006	CMS Approval Date 2019-05-17	Category B
Study Title Interscope Endorotor® Mucosal Resection System With Continued Ablative Therapy In Subjects With Refractory Dysplastic Barrett's Esophagus	Sponsor Name Interscope, Inc.	NCT Number NCT03364114	IDE Number G170106	CMS Approval Date 2019-05-17	Category B
Study Title Single Arm, Prospective, Open Label, Multicenter Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems in the Visualization of Lymphatic Vessels and Lymph Nodes During Lymphatic Mapping and Sentinel Lymph Node Biopsy ...	Sponsor Name Novadaq Technologies ULC, now a part of Stryker	NCT Number NCT03200704	IDE Number G170109	CMS Approval Date 2019-05-17	Category B
Study Title Tailoring Maintenance Therapy to CD5+ Regulatory B Cell Recovery in ANCA Vasculitis	Sponsor Name University of North Carolina, Chapel Hill	NCT Number NCT03906227	IDE Number G180297	CMS Approval Date 2019-05-17	Category B
Study Title A Randomized, Controlled, Open-labeled, Multi-center Clinical Trial to Evaluate the Safe and Effective Performance of the Lungpacer Diaphragm Pacing Therapy System in Patients Who Have Failed to Wean From Mechanical Ventilation	Sponsor Name Lungpacer Medical Inc.	NCT Number NCT03783884	IDE Number G180237	CMS Approval Date 2019-05-09	Category A
Study Title A Randomized, Multicenter, Controlled, Unblinded Study to Assess the Safety and Efficacy of the NanoKnife® System for the Ablation of Unresectable Stage 3 Pancreatic Adenocarcinoma	Sponsor Name Angiodynamics, Inc.	NCT Number NCT03899636	IDE Number G180278	CMS Approval Date 2019-05-03	Category B
Study Title A Prospective, Open-Label, Multicenter Pivotal Study to Evaluate the Safety and Efficacy of GelrinC® for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle: A Comparison to Historical Control Microfracture	Sponsor Name Regentis Biomaterials	NCT Number NCT03262909	IDE Number G160184	CMS Approval Date 2019-04-26	Category B
Study Title Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms	Sponsor Name W.L.Gore & Associates	NCT Number NCT03728985	IDE Number G150071	CMS Approval Date 2019-04-25	Category B
Study Title SELECT 2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke	Sponsor Name The University of Texas Health Science Center, Houston	NCT Number NCT03876457	IDE Number G180275	CMS Approval Date 2019-04-25	Category B
Study Title Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator (ICD) Implantation to Prevent Tachyarrhythmias Following Acute Myocardial Infarction (PROTECT-ICD)	Sponsor Name Western Sydney Local Health District	NCT Number NCT03588286	IDE Number G180208	CMS Approval Date 2019-04-25	Category B
Study Title XIENCE 28 USA Study	Sponsor Name Abbott Medical Devices	NCT Number NCT03815175	IDE Number G170081	CMS Approval Date 2019-04-01	Category B
Study Title Cochlear Implantation During Vestibular Schwannoma Removal or During Labyrinthectomy Surgery for Treatment of Meniere's Disease	Sponsor Name Ohio State University	NCT Number NCT03795675	IDE Number G170139	CMS Approval Date 2019-03-15	Category B
Study Title The Use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) as an Adjunct to Advanced Cardiac Life Support in Non-traumatic Cardiac Arrest: an Early Feasibility Trial	Sponsor Name Yale University	NCT Number NCT03703453	IDE Number G170307	CMS Approval Date 2019-02-28	Category A
Study Title LifePort® Liver Transporter System and Vasosol® Machine Perfusion Solution	Sponsor Name Organ Recovery Systems	NCT Number NCT03484455	IDE Number G030132	CMS Approval Date 2019-02-22	Category B
Study Title Evaluation of the QDOT MICRO™ Catheter for pulmonary vein isolation in subjects with Paroxysmal Atrial Fibrillation	Sponsor Name Biosense Webster, Inc.	NCT Number NCT03775512	IDE Number G180176	CMS Approval Date 2019-02-22	Category B
Study Title OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study	Sponsor Name Svelte Medical Systems, Inc.	NCT Number NCT03716102	IDE Number G160227	CMS Approval Date 2019-02-15	Category B
Study Title AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery	Sponsor Name AtriCure, Inc.	NCT Number NCT03732794	IDE Number G180173	CMS Approval Date 2019-02-15	Category B
Study Title A Pilot Protocol Evaluating Safety of Using the Medtronic Pump and Codman Catheter for the Delivery of Hepatic Arterial Infusion (HAI) Chemotherapy in Patients With Colorectal Carcinoma or Cholangiocarcinoma	Sponsor Name Memorial Sloan Kettering Cancer Center	NCT Number NCT03693807	IDE Number G180175	CMS Approval Date 2019-02-08	Category B
Study Title CLASP TR EFS	Sponsor Name Edwards Lifesciences	NCT Number NCT03745313	IDE Number G180266	CMS Approval Date 2019-02-01	Category A
Study Title Randomized, Controlled, Single-blind Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects With Complete Thoracic AIS A Spinal Cord Injury as Compared to Standard of Care	Sponsor Name InVivo Therapeutics	NCT Number NCT03762655	IDE Number G110119	CMS Approval Date 2019-02-01	Category A
Study Title Cross-SealTM IDE Trial: Prospective, Multi-Center, Single Arm Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System	Sponsor Name Terumo Medical Corporation	NCT Number NCT03756558	IDE Number G180143	CMS Approval Date 2019-01-25	Category B
Study Title A Multicenter, Prospective Study of EUS-Guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage	Sponsor Name Boston Scientific Corporation	NCT Number NCT03767881	IDE Number G170190	CMS Approval Date 2019-01-25	Category B
Study Title Scoreflex NC - Scoring PTCA Catheter: A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Safety and Device Procedural Success of the Scoreflex NC Scoring PTCA Catheter in Subjects With Stenotic Coronary Arter...	Sponsor Name OrbusNeich	NCT Number NCT03763747	IDE Number G180168	CMS Approval Date 2019-01-25	Category B
Study Title Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)	Sponsor Name Biosense Webster, Inc.	NCT Number NCT03683030	IDE Number G180139-1	CMS Approval Date 2019-01-10	Category B
Study Title Prospective, Multicenter, Single-Arm, Global IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2 Coronary IVL Catheter in Calcified Coronary Arteries	Sponsor Name Shockwave Medical, Inc.	NCT Number NCT03595176	IDE Number G180146	CMS Approval Date 2018-12-13	Category B
Study Title Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens	Sponsor Name AcuFocus, Inc.	NCT Number NCT03633695	IDE Number G180075	CMS Approval Date 2018-12-13	Category B
Study Title Noninvasive Biomarkers to Advance Emerging DBS Electrode Technologies in Parkinson's Disease	Sponsor Name University of Alabama at Birmingham	NCT Number NCT03353688	IDE Number G170063	CMS Approval Date 2018-11-30	Category B
Study Title Prospective, Trial Evaluating the Safety and Effectiveness of the Interscope Endorotor® System for Direct Endoscopic Necrosectomy of Walled Off Pancreatic Necrosis	Sponsor Name Interscope, Inc.	NCT Number NCT03694210	IDE Number G180127	CMS Approval Date 2018-11-30	Category B
Study Title Evaluation of the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System to Treat Peripheral Artery Disease	Sponsor Name Cardio Flow, Inc.	NCT Number NCT03635190	IDE Number G170219	CMS Approval Date 2018-11-30	Category B
Study Title SYNergy Stent® System Implantation With Mandatory Intra-VascularUltra-Sound Guidance to Examine the Safety of Cessation of Dual Anti-Platelet Therapy in High Bleeding Risk Patients at One Month	Sponsor Name HonorHealth Research Institute	NCT Number NCT03606642	IDE Number G180024	CMS Approval Date 2018-11-16	Category B
Study Title BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction	Sponsor Name Biotronik SE & Co. KG	NCT Number NCT02341534	IDE Number G180155	CMS Approval Date 2018-11-16	Category B
Study Title A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System	Sponsor Name Medtronic Vascular	NCT Number NCT03584464	IDE Number G140178	CMS Approval Date 2018-11-16	Category B
Study Title Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility	Sponsor Name Lung Bioengineering Inc.	NCT Number NCT03641677	IDE Number G170312	CMS Approval Date 2018-11-09	Category B
Study Title Pivotal Study of the LUM Imaging System for Assisting Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Patients With Breast Cancer	Sponsor Name Lumicell, Inc.	NCT Number NCT03686215	IDE Number G140195	CMS Approval Date 2018-11-09	Category B
Study Title Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)	Sponsor Name Medtronic Cardiovascular	NCT Number NCT03546374	IDE Number G170283-1	CMS Approval Date 2018-11-01	Category B
Study Title An Open-Label Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel Plus Trastuzumab and Pertuzumab in Early Stage HER2-Negative Breast Cancer Patients Selected with a Test Measur...	Sponsor Name Celcuity	NCT Number NCT03412643	IDE Number G160277	CMS Approval Date 2018-10-26	Category B
Study Title The "RADIANCE II" Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension	Sponsor Name ReCor Medical, Inc.	NCT Number NCT03614260	IDE Number G150144	CMS Approval Date 2018-10-26	Category B
Study Title Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique (BURN)	Sponsor Name Erbe Elektromedizin GmbH	NCT Number NCT03621319	IDE Number G180034	CMS Approval Date 2018-10-19	Category B
Study Title CRYSTAL Study: A Multi-Center, Randomized, Controlled Trial to Demonstrate the Safety and Effectiveness of the MiStent II for the Revascularization of Coronary Arteries.	Sponsor Name Micell Technologies	NCT Number NCT03423511	IDE Number G170030	CMS Approval Date 2018-10-12	Category B
Study Title Proposed Single Center Investigational Device Exemption: Feasibility of Endovascular Repair of Ascending Aortic Pathologies	Sponsor Name Baylor Research Institute	NCT Number NCT03322033	IDE Number G170196	CMS Approval Date 2018-10-12	Category B
Study Title ADvance II: A 12-month Double-blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Deep Brain Stimulation of the Fornix (DBS-f) in Patients With Mild Probable Alzheimer's Disease	Sponsor Name Functional Neuromodulation Ltd	NCT Number NCT03622905	IDE Number G110220	CMS Approval Date 2018-10-12	Category B
Study Title High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study	Sponsor Name Neuros Medical, Inc.	NCT Number NCT02221934	IDE Number G130203	CMS Approval Date 2018-10-12	Category B
Study Title Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation (PERSIST-END IDE)	Sponsor Name St. Jude Medical	NCT Number NCT03650556	IDE Number G180149	CMS Approval Date 2018-10-12	Category B
Study Title A Prospective Clinical Evaluation of the DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation	Sponsor Name EPIX Therapeutics	NCT Number NCT03643224	IDE Number G180153	CMS Approval Date 2018-10-05	Category B
Study Title A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients Undergoing Complex Cardiac Surgery Procedures	Sponsor Name Cerus Corporation	NCT Number NCT03459287	IDE Number BB13803	CMS Approval Date 2018-10-05	Category A
Study Title TriCinch Coil System	Sponsor Name 4Tech Cardio Ireland Limited	NCT Number NCT03632967	IDE Number G180151	CMS Approval Date 2018-09-28	Category A
Study Title A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease	Sponsor Name InnAVasc Medical, Inc.	NCT Number NCT03645681	IDE Number G180188	CMS Approval Date 2018-09-28	Category B
Study Title Onyx ONE Clear: A Single Arm Study With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)	Sponsor Name Medtronic Vascular	NCT Number NCT03647475	IDE Number G140178	CMS Approval Date 2018-09-28	Category B
Study Title CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™	Sponsor Name Vascular Dynamics, Inc.	NCT Number NCT03179800	IDE Number G130013	CMS Approval Date 2018-09-21	Category B
Study Title ArcticLine Feasibility Study	Sponsor Name Medtronic Atrial Fibrillation Solutions	NCT Number NCT03604263	IDE Number G170182	CMS Approval Date 2018-09-13	Category A
Study Title An Early Feasibility Evaluation of the AccuCinch® Ventricular Repair System in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF) - The CorCinch-HFrEF Study	Sponsor Name Ancora Heart, Inc.	NCT Number NCT03533517	IDE Number G150249	CMS Approval Date 2018-09-13	Category A
Study Title An Early Feasibility Study of the AccuCinch® Ventricular Repair System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation - The CorCinch-PMVI Study	Sponsor Name Ancora Heart, Inc.	NCT Number NCT03560167	IDE Number G150249	CMS Approval Date 2018-09-13	Category A
Study Title Clinical Evaluation of the Serenity River Stent System to Treat Idiopathic Intracranial Hypertension	Sponsor Name Serenity Medical, Inc.	NCT Number NCT03556085	IDE Number G180008	CMS Approval Date 2018-08-23	Category B
Study Title RELIEVE-HF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure	Sponsor Name V-Wave Ltd	NCT Number NCT03499236	IDE Number G180020	CMS Approval Date 2018-08-15	Category B
Study Title Multi-center, Single Arm Continuing Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) for the Management of the Femoral Venotomy After Catheter-based Interventions Performed Via 6-12 Fr Procedural Sheaths With Single o...	Sponsor Name Cardiva Medical, Inc.	NCT Number NCT03573206	IDE Number G170144	CMS Approval Date 2018-08-15	Category B
Study Title Prospective, Randomized, Multi-Center Study to Evaluate Treatment of Subjects With Occlusive Disease With a Novel Paclitaxel-Coated Angioplasty Balloon in Below-The-Knee (BTK) Arteries - ILLUMENATE BTK	Sponsor Name Spectranetics Corporation	NCT Number NCT03175744	IDE Number G160220	CMS Approval Date 2018-08-07	Category B
Study Title Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects With Mitral Annular Calcification	Sponsor Name Tendyne Holdings, Inc.	NCT Number NCT03539458	IDE Number G140240	CMS Approval Date 2018-08-03	Category B
Study Title An Open-Label Clinical Study to Assess the Performance of the Dialyzer With Endexo™ in End-Stage Renal Disease Subjects	Sponsor Name Fresenius Medical Care North America	NCT Number NCT03536663	IDE Number G180016	CMS Approval Date 2018-07-24	Category A
Study Title Task and Physiological Specific Stimulation for Recovery of Autonomic Function, Voluntary Movement, and Standing Using Epidural Stimulation and Training After Severe Spinal Cord Injury	Sponsor Name University of Louisville	NCT Number NCT03364660	IDE Number G090174	CMS Approval Date 2018-07-20	Category B
Study Title A Randomized Trial Comparing the Drug-Eluting Stent (DES) Below-the-Knee (BTK) Vascular Stent System (DES BTK Vascular Stent System) vs Percutaneous Transluminal Angioplasty (PTA) Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia	Sponsor Name Boston Scientific Corporation	NCT Number NCT03551496	IDE Number G180073	CMS Approval Date 2018-07-13	Category B
Study Title PHIL dAVF: Study of PHIL® Embolic System In The Treatment of Intracranial Dural Arteriovenous Fistulas	Sponsor Name Microvention-Terumo, Inc.	NCT Number NCT03467542	IDE Number G170203	CMS Approval Date 2018-06-27	Category B
Study Title ROBUST III - Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease - A Randomized Control Trial	Sponsor Name Urotronic Inc.	NCT Number NCT03499964	IDE Number G180041	CMS Approval Date 2018-06-21	Category B
Study Title OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI	Sponsor Name St. Jude Medical	NCT Number NCT03507777	IDE Number G180052	CMS Approval Date 2018-06-21	Category B
Study Title Next-Generation TECNIS Symfony Extended Range of Vision IOL	Sponsor Name Johnson & Johnson Surgical Vision, Inc.	NCT Number NCT03500198	IDE Number G180044	CMS Approval Date 2018-06-21	Category B
Study Title The Mount Sinai Diabetic Foot Ulcer Prospective Trial	Sponsor Name Windsor Ting	NCT Number NCT03404895	IDE Number G170254	CMS Approval Date 2018-06-15	Category B
Study Title LC Bead LUMI for Prostatic Artery Embolization: A Pilot Study	Sponsor Name University of North Carolina, Chapel Hill	NCT Number NCT03372096	IDE Number G170232	CMS Approval Date 2018-06-15	Category B
Study Title Evaluation of the Tissue Genesis Icellator Cell Isolation System to Treat Erectile Dysfunction	Sponsor Name Tissue Genesis, LLC	NCT Number NCT03518333	IDE Number BB14861	CMS Approval Date 2018-06-15	Category B
Study Title A Multicenter, Single-arm Study of Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis With Lumen-Apposing Metal Stents	Sponsor Name Boston Scientific Corporation	NCT Number NCT03525808	IDE Number G170261	CMS Approval Date 2018-06-08	Category B
Study Title FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of Ventricular Tachycardia (LESS-VT) Study	Sponsor Name St. Jude Medical	NCT Number NCT03490201	IDE Number G170221	CMS Approval Date 2018-05-23	Category B
Study Title A 2x2 Factorial Randomized Controlled Trial of Colchicine and Spironolactone in Patients With ST-elevation Myocardial Infarction (STEMI) / SYNERGY Stent Registry - CLEAR-SYNERGY (OASIS-9)	Sponsor Name Population Health Research Institute	NCT Number NCT03048825	IDE Number G170179	CMS Approval Date 2018-05-23	Category B
Study Title A Validation of the Assisted Fluid Management Feature	Sponsor Name Edwards Lifesciences	NCT Number NCT03469570	IDE Number G170204	CMS Approval Date 2018-05-22	Category A
Study Title A Multi-Center, Prospective Clinical Trial To Evaluate The Safety And Effectiveness of the CT LUCIA 611p Posterior Chamber Intraocular Lens For Correction of Aphakia Following Cataract Removal	Sponsor Name Carl Zeiss Medictec Production, LLC	NCT Number NCT03451786	IDE Number G170266	CMS Approval Date 2018-05-21	Category A
Study Title Tendyne Mitral Valve System	Sponsor Name Abbott	NCT Number NCT03433274	IDE Number G140240	CMS Approval Date 2018-05-08	Category B
Study Title EVOLVE 48: A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of the SYNERGY 48 mm Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)	Sponsor Name Boston Scientific Corporation	NCT Number NCT03350542	IDE Number G170282	CMS Approval Date 2018-05-07	Category B
Study Title Randomized Controlled Pivotal Trial of Autologous Bone Marrow Cells Using the CardiAMP Cell Therapy System in Patients With Refractory Angina Pectoris and Chronic Myocardial Ischemia (CardiAMP CMI Trial)	Sponsor Name BioCardia, Inc.	NCT Number NCT03455725	IDE Number BB17905	CMS Approval Date 2018-05-02	Category B
Study Title Treatment With Intent to Generate Endovascular Reperfusion	Sponsor Name Rapid Medical	NCT Number NCT03474549	IDE Number G180004	CMS Approval Date 2018-05-01	Category B
Study Title INVEST: A Single Arm, Feasibility Study of Minimally Invasive Endoscopic Surgical Treatment With Apollo for Supratentorial Intracerebral Hemorrhage (ICH)	Sponsor Name J. Mocco	NCT Number NCT02654015	IDE Number G150222	CMS Approval Date 2018-04-27	Category B
Study Title Safety and Feasibility of Adipose Derived Regenerative Cells (ADRCs) in the Treatment of Deep Partial Thickness and Full Thickness Thermal Wounds (RELIEF)	Sponsor Name Cytori Therapeutics	NCT Number NCT03435172	IDE Number BB17234	CMS Approval Date 2018-04-27	Category B
Study Title MIND: A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage	Sponsor Name Penumbra Inc.	NCT Number NCT03342664	IDE Number G170129	CMS Approval Date 2018-04-27	Category B
Study Title INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage: A Prospective Multicenter Registry	Sponsor Name J. Mocco	NCT Number NCT02661672	IDE Number G150222-1	CMS Approval Date 2018-04-27	Category B
Study Title Confirmatory Clinical Study to Support the Effectiveness and Safety of Oxiplex for the Reduction of Pain and Symptoms Following Lumbar Surgery	Sponsor Name FzioMed	NCT Number NCT03433391	IDE Number G170195	CMS Approval Date 2018-04-12	Category B
Study Title P-15L Bone Graft	Sponsor Name Cerapedics, Inc.	NCT Number NCT03438747	IDE Number G170300	CMS Approval Date 2018-04-12	Category B
Study Title Wearable Sensor Driven Closed-loop Deep Brain Stimulation for Essential Tremor	Sponsor Name University of Florida	NCT Number NCT03051178	IDE Number G170302	CMS Approval Date 2018-04-04	Category A
Study Title Local Field Potential (LFP) Beta Adaptive Deep Brain Stimulation (aDBS) Feasibility Study	Sponsor Name MedtronicNeuro	NCT Number NCT03446833	IDE Number G170191	CMS Approval Date 2018-04-04	Category B
Study Title GORE PV1 Device	Sponsor Name W. L. Gore & Associates	NCT Number NCT03441971	IDE Number G170289	CMS Approval Date 2018-04-04	Category A
Study Title Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Gemcitabine and Nab-paclitaxel for Front-line Treatment of Locally-advanced Pancreatic Adenocarcinoma	Sponsor Name NovoCure Ltd.	NCT Number NCT03377491	IDE Number G170288	CMS Approval Date 2018-04-04	Category A
Study Title PQ Bypass System for Femoropopliteal Bypass II	Sponsor Name PQ Bypass, Inc.	NCT Number NCT03119233	IDE Number G170083	CMS Approval Date 2018-03-23	Category B
Study Title Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System (OCS™) Lung System for Recruiting, Preserving and Assessing Non-Ideal Donor Lungs for Transplantation	Sponsor Name TransMedics	NCT Number NCT03343535	IDE Number G130019	CMS Approval Date 2018-03-23	Category B
Study Title MED-EL SYNCRONY Cochlear Implant System	Sponsor Name MED-EL Corporation	NCT Number NCT03236909	IDE Number G170111	CMS Approval Date 2018-03-15	Category B
Study Title Metabolic Mapping and Cardiac Resynchronization (Aim 1)	Sponsor Name Yong-Mei Cha	NCT Number NCT03420833	IDE Number G150177	CMS Approval Date 2018-03-14	Category B
Study Title A Non-Randomized Study Evaluating the Use of the ReFlow Medical Wingman Catheter to Cross Chronic Total Occlusions in Infrainguinal Peripheral ArTeries	Sponsor Name ReFlow Medical, Inc.	NCT Number NCT03403426	IDE Number G170251	CMS Approval Date 2018-03-13	Category B
Study Title A Prospective, Multi-center, Single Arm Study to Evaluate the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial A...	Sponsor Name Pulsar Vascular	NCT Number NCT03383666	IDE Number G170220	CMS Approval Date 2018-02-27	Category A
Study Title Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy - The C-TRACT Trial	Sponsor Name Washington University School of Medicine	NCT Number NCT03250247	IDE Number G170161	CMS Approval Date 2018-02-27	Category B
Study Title Hemodynamic-GUIDEd Management of Heart Failure	Sponsor Name Abbott	NCT Number NCT03387813	IDE Number G170258	CMS Approval Date 2018-02-23	Category B
Study Title LUNAR: Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields) Concurrent With Standard of Care Therapies for Treatment of Stage 4 Non-small Cell Lung Cancer (NSCLC) Following Platinum Failure	Sponsor Name NovoCure Ltd.	NCT Number NCT02973789	IDE Number G170238	CMS Approval Date 2018-02-15	Category A
Study Title Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study	Sponsor Name Edwards Lifesciences	NCT Number NCT03382457	IDE Number G170284	CMS Approval Date 2018-02-15	Category A
Study Title JETStream AtheRectomy With Adjunctive Paclitaxel-Coated BallooN Angioplasty vs Balloon AnGioplasty Followed by Paclitaxel-Coated Balloon in Treating ComplEx Denovo FemoRopopliteal Arterial Disease (JET-RANGER)	Sponsor Name Midwest Cardiovascular Research Foundation	NCT Number NCT03206762	IDE Number G170066	CMS Approval Date 2018-02-08	Category B
Study Title CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery (REFRESH II Trial)	Sponsor Name CytoSorbents, Inc	NCT Number NCT03384875	IDE Number G140256	CMS Approval Date 2018-02-02	Category A
Study Title Clinical Study Protocol for the Investigation Of The Two Level Simplify® Cervical Artificial Disc	Sponsor Name Simplify Medical Inc.	NCT Number NCT03123549	IDE Number G150206	CMS Approval Date 2018-02-02	Category B
Study Title Panoramic ECGi to Guide Ablation of Non-Paroxysmal AF: Effect of Ibutilide on AF Source Location and Organization	Sponsor Name Vivek Reddy	NCT Number NCT03370536	IDE Number G170065	CMS Approval Date 2018-01-26	Category B
Study Title Double Blind, Phase I, Randomized, Parallel Group Study of Hip Decompression Compared to Hip Decompression Supplemented at the Point of Care With Adipose Derived Regenerative Cells for Bilateral Pre-Collapse Femoral Head Osteonecrosis	Sponsor Name Mayo Clinic	NCT Number NCT03269409	IDE Number BB17455	CMS Approval Date 2018-01-26	Category B
Study Title A Prospective, Multi-Center, Randomized Concurrently Controlled Trial to Evaluate the Safety and Effectiveness of the Altum® Pedicle Osteotomy System for Use in Lumbar Spinal Stenosis	Sponsor Name Innovative Surgical Designs	NCT Number NCT03381677	IDE Number G110179	CMS Approval Date 2018-01-26	Category A
Study Title TECNIS® Next-Generation Intraocular Lenses (IOLs), Models ZFR00 and ZYR00	Sponsor Name Abbott Medical Optics Inc.	NCT Number NCT03372434	IDE Number G170243	CMS Approval Date 2018-01-19	Category A
Study Title Left Atrial Anatomy Reconstruction Using Model Based Fast Anatomical Mapping	Sponsor Name Vivek Reddy	NCT Number NCT03349476	IDE Number G170110	CMS Approval Date 2018-01-10	Category B
Study Title Multi-Center Acute Safety Trial of TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the Treatment of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation	Sponsor Name Abbott	NCT Number NCT03354663	IDE Number G170245	CMS Approval Date 2018-01-10	Category B
Study Title Artimes Pro Low Profile 1.00mm and 1.25mm Dilatation Catheters for Pre-Dilatation of Stenosis and Occlusion in Patients With Symptomatic Ischemic Heart Disease	Sponsor Name Eminence Clinical Research, Inc.	NCT Number NCT03301246	IDE Number G170090	CMS Approval Date 2018-01-08	Category B
Study Title Pilot Study to Examine the Feasibility of the DISCSS™	Sponsor Name Meagan Medical	NCT Number NCT03341000	IDE Number G170169	CMS Approval Date 2018-01-03	Category B
Study Title RCStim Model 1114R or 1114L Soft Tissue Stimulator	Sponsor Name Orthofix, Inc.	NCT Number NCT03339492	IDE Number G170147	CMS Approval Date 2018-01-02	Category B
Study Title A Randomized Controlled Clinical Evaluation of the DiamondTemp™ System for the Treatment of Paroxysmal Atrial Fibrillation	Sponsor Name Advanced Cardiac Therapeutics	NCT Number NCT03334630	IDE Number G170227	CMS Approval Date 2017-12-22	Category B
Study Title TSolution One® Total Knee Arthroplasty Clinical Trial	Sponsor Name Think Surgical Inc.	NCT Number NCT03017261	IDE Number G160094	CMS Approval Date 2017-12-22	Category B
Study Title Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias	Sponsor Name Vivek Reddy	NCT Number NCT03204981	IDE Number G170067	CMS Approval Date 2017-12-15	Category B
Study Title Evaluate the Efficacy and Safety of RBCs Derived From Mirasol-treated Whole Blood Compared With Conventional RBCs in Patients Requiring Chronic Transfusion Support	Sponsor Name Terumo BCTbio	NCT Number NCT03329404	IDE Number BB15025	CMS Approval Date 2017-12-12	Category A
Study Title Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms	Sponsor Name University of South Florida	NCT Number NCT03075748	IDE Number G170024	CMS Approval Date 2017-11-28	Category B
Study Title A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula	Sponsor Name Laminate Medical Technologies	NCT Number NCT03242343	IDE Number G170039	CMS Approval Date 2017-11-24	Category B
Study Title Real-time Electrogram Analysis for Drivers of AtRial Fibrillation (RADAR)	Sponsor Name Vivek Reddy	NCT Number NCT03263702	IDE Number G170049	CMS Approval Date 2017-11-10	Category B
Study Title Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)	Sponsor Name Evalve	NCT Number NCT03227757	IDE Number G170118	CMS Approval Date 2017-11-07	Category A
Study Title The Effectiveness of Early Sacral Nerve Stimulation in Improving Bladder- Related Complications and Quality of Life After Acute Traumatic Spinal Cord Injury	Sponsor Name University of Utah	NCT Number NCT03083366	IDE Number G160136	CMS Approval Date 2017-11-06	Category B
Study Title A Prospective, Multi-Center, Randomized, Controlled, Pivotal Trial to Validate the Safety and Efficacy of the Hemolung® Respiratory Assist System for COPD Patients Experiencing an Acute Exacerbation Requiring Ventilatory Support	Sponsor Name Alung Technologies	NCT Number NCT03255057	IDE Number G170096	CMS Approval Date 2017-10-31	Category B
Study Title SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma (SIRCCA)	Sponsor Name Sirtex Medical	NCT Number NCT02807181	IDE Number G160128	CMS Approval Date 2017-10-26	Category B
Study Title AcrySof IQ PanOptix Intraocular Lens	Sponsor Name Alcon Research, Ltd.	NCT Number NCT03280108	IDE Number G170172	CMS Approval Date 2017-10-26	Category B
Study Title SAPIEN M3 System	Sponsor Name Edwards Lifesciences LLC	NCT Number NCT03230747	IDE Number G170152	CMS Approval Date 2017-10-26	Category A
Study Title Proposed Single Center Investigational Device Exemption: Endovascular Repair of Descending ThoracoAbdominal Aortic Pathologies Using Physician Modified Endovascular Prosthesis	Sponsor Name Rodney A. White, M.D.	NCT Number NCT02524834	IDE Number G150087	CMS Approval Date 2017-10-23	Category B
Study Title Intravascular Ventricular Assist System (iVAS)	Sponsor Name NuPulseCV, Inc.	NCT Number NCT02645539	IDE Number G150242	CMS Approval Date 2017-10-23	Category B
Study Title Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study (SITRAL)	Sponsor Name Baylor Research Institute	NCT Number NCT02830204	IDE Number G160024	CMS Approval Date 2017-10-16	Category B
Study Title AcrySof®IQ Extended Depth of Focus (EDF) Intraocular Lens (IOL)	Sponsor Name Alcon Research, Ltd.	NCT Number NCT03274986	IDE Number G170175	CMS Approval Date 2017-10-12	Category B
Study Title Theranova 400 Dialyzer	Sponsor Name Baxter Healthcare Corporation	NCT Number NCT03257410	IDE Number G170157	CMS Approval Date 2017-10-11	Category B
Study Title Deep Brain Stimulation (DBS) in Patients With Refractory Chronic Neuropathic Pain	Sponsor Name University of California, San Francisco	NCT Number NCT03029884	IDE Number G160018	CMS Approval Date 2017-10-11	Category A
Study Title INSIGHT: EvaluatIoN of the PantheriS OCT- ImaGing AtHerectomy SysTem For Treatment of In-Stent Restenosis (ISR) Lesions In Lower Extremity Arteries	Sponsor Name Avinger, Inc.	NCT Number NCT03192696	IDE Number G170078	CMS Approval Date 2017-10-03	Category B
Study Title The Randomized And Controlled Noninferiority Trial to Evaluate Safety and Clinical Efficacy of the SurVeil™ Drug-Coated Balloon iN the Treatment of Subjects With Stenotic Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT® Admiral�...	Sponsor Name SurModics, Inc.	NCT Number NCT03241459	IDE Number G150121	CMS Approval Date 2017-10-03	Category B
Study Title Intrepid Transcatheter Mitral Valve Replacement System	Sponsor Name Medtronics	NCT Number NCT03242642	IDE Number G160020	CMS Approval Date 2017-09-26	Category B
Study Title Randomized Trial Of Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention	Sponsor Name Emilia Bagiella	NCT Number NCT03089398	IDE Number G170154	CMS Approval Date 2017-09-22	Category B
Study Title Safety and Effectiveness Evaluation of Eximo Medical's B-LaserTM, a Hybrid Atherectomy Device, in Subjects Affected with Infrainguinal PAD	Sponsor Name Eximo Medical Ltd	NCT Number NCT03157531	IDE Number G170104	CMS Approval Date 2017-09-20	Category B
Study Title Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms	Sponsor Name New York University School of Medicine	NCT Number NCT03246126	IDE Number G170048	CMS Approval Date 2017-09-12	Category B
Study Title A Prospective, Multicenter Trial to Evaluate the Safety and Efficacy of the Indigo Aspiration System in Acute Submassive Pulmonary Embolism	Sponsor Name Penumbra Inc.	NCT Number NCT03218566	IDE Number G170064	CMS Approval Date 2017-09-08	Category B
Study Title A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Probable Benefit of the KeraKlear Non-Penetrating Keratoprosthesis in Subjects With Corneal Opacity With Poor Prognosis for Corneal Transplant	Sponsor Name KeraMed, Inc.	NCT Number NCT03126903	IDE Number G150267	CMS Approval Date 2017-09-08	Category A
Study Title Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal Aortic Aneurysms	Sponsor Name University of Colorado, Denver	NCT Number NCT02989948	IDE Number G160207	CMS Approval Date 2017-09-08	Category B
Study Title Epidural Stimulation for Spinal Cord Injury	Sponsor Name University of Minnesota - Clinical and Translational Science Institute	NCT Number NCT03026816	IDE Number G160247	CMS Approval Date 2017-08-30	Category B
Study Title PARTNER 3 Trial - Mitral Valve in Valve is a Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve	Sponsor Name Edwards Lifesciences	NCT Number NCT03193801	IDE Number G150278	CMS Approval Date 2017-08-25	Category B
Study Title XIENCE Short DAPT Study	Sponsor Name Abbott Vascular	NCT Number NCT03218787	IDE Number G170081	CMS Approval Date 2017-08-24	Category B
Study Title A Prospective Global Randomized Trial Assessing the Safety and Efficacy of the BuMA Supreme™ Biodegradable Drug Coated Coronary Stent System for Coronary Revascularization in Patients With Stable Coronary Artery Disease or Non-ST Segment Elevation Acute...	Sponsor Name Sino Medical Sciences Technology Inc.	NCT Number NCT03168776	IDE Number G160235	CMS Approval Date 2017-08-22	Category B
Study Title A Prospective, Multicenter, Non-Blinded, Non-Randomized Early Feasibility Study of the Relay Branch Thoracic Stent-Graft System in Subjects With Thoracic Aortic Pathologies Requiring Treatment Proximal to the Origin of the Innominate Artery	Sponsor Name Bolton Medical	NCT Number NCT03214601	IDE Number G160237	CMS Approval Date 2017-08-18	Category A
Study Title The OPTIMIZE Trial to Assess the Procedural and Clinical Value of the Svelte IDS and RX Sirolimus Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions in a Randomized Study	Sponsor Name Svelte Medical Systems, Inc.	NCT Number NCT03190473	IDE Number G160227	CMS Approval Date 2017-08-18	Category B
Study Title An Open Label, Single Arm Pilot Study of OncoSil™, Administered to Subjects With Unresectable Locally Advanced Pancreatic Adenocarcinoma, Given in Combination With Gemcitabine or Gemcitabine+Nab-paclitaxel Chemotherapies	Sponsor Name OncoSil Medical Limited	NCT Number NCT03076216	IDE Number G150271	CMS Approval Date 2017-08-17	Category B
Study Title A Multi-center, Randomized, Within-subject-controlled, Open Label Study of the Safety and Effectiveness of VEST, Venous External Support	Sponsor Name Vascular Graft Solutions Ltd.	NCT Number NCT03209609	IDE Number G150225	CMS Approval Date 2017-08-10	Category B
Study Title Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL)	Sponsor Name Alcon Laboratories, Inc.	NCT Number NCT03170154	IDE Number G170112	CMS Approval Date 2017-08-10	Category B
Study Title Prospective, Randomized, Double-Blinded, Controlled Multi-Center Clinical Trial Evaluating the Use of Non-Invasive CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures	Sponsor Name Encore Medical, L.P.	NCT Number NCT02688855	IDE Number G150262	CMS Approval Date 2017-08-10	Category B
Study Title Cardiva Mid-Bore Venous Vascular Closure System (VVCS)	Sponsor Name Cardiva Medical, Inc.	NCT Number NCT03193021	IDE Number G170144	CMS Approval Date 2017-08-03	Category B
Study Title Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST - MST)	Sponsor Name University of Texas Southwestern Medical Center	NCT Number NCT03191058	IDE Number G170127	CMS Approval Date 2017-08-03	Category B
Study Title Evaluation of the Surfacer System Approach to Central Venous Access	Sponsor Name Bluegrass Vascular Technologies	NCT Number NCT03209050	IDE Number G170045	CMS Approval Date 2017-08-03	Category A
Study Title Multicenter Early Feasibility Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 Transcather Heart Valve With the Alterra Adaptive Prestent	Sponsor Name Edwards Lifesciences	NCT Number NCT03130777	IDE Number G170053	CMS Approval Date 2017-07-21	Category B
Study Title Haploidentical CD34+ Selected Cells Combined With Single Unit Umbilical Cord Blood Transplant for Treatment of High-risk Hematologic Disorders	Sponsor Name University of Colorado, Denever	NCT Number NCT03093844	IDE Number BB17240	CMS Approval Date 2017-07-07	Category B
Study Title Cardiogenic Shock Intravascular Cooling Trial (CHILL-SHOCK)	Sponsor Name University of Chicago	NCT Number NCT03141255	IDE Number G160183	CMS Approval Date 2017-06-22	Category B
Study Title Attain Stability™ Quad Clinical Study	Sponsor Name Medtronic Cardiac Rhythm and Heart Failure	NCT Number NCT03099655	IDE Number G170020	CMS Approval Date 2017-06-22	Category B
Study Title Operative Procedures vs. Endovascular Neurosurgery for Untreated Pseudotumor Trial (OPEN-UP)	Sponsor Name St. Joseph's Hospital and Medical Center, Phoenix	NCT Number NCT02513914	IDE Number G160232	CMS Approval Date 2017-06-22	Category B
Study Title Medtronic TAAA Debranching Stent Graft System	Sponsor Name Vanderbilt University Medical Center	NCT Number NCT03113383	IDE Number G160182	CMS Approval Date 2017-06-22	Category B
Study Title Cardioband Mitral System	Sponsor Name Edwards Lifesciences Corporation	NCT Number NCT03016975	IDE Number G160246	CMS Approval Date 2017-06-22	Category B
Study Title Deep Brain Stimulation to Relieve Depression	Sponsor Name University of Pittsburgh	NCT Number NCT02889250	IDE Number G160025	CMS Approval Date 2017-06-08	Category B
Study Title STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation	Sponsor Name Medtronic Atrial Fibrillation Solutions	NCT Number NCT03118518	IDE Number G160219	CMS Approval Date 2017-06-06	Category B
Study Title Assessment of the Carillon® Mitral Contour System® in Treating Functional Mitral Regurgitation Associated With Heart Failure	Sponsor Name Cardiac Dimensions Pty Ltd	NCT Number NCT03142152	IDE Number G160223	CMS Approval Date 2017-06-06	Category B
Study Title RELIEF Study: A Prospective, Multicenter Study of REflux Management With the LINX® System for Gastroesophageal REFlux Disease After Laparoscopic Sleeve Gastrectomy	Sponsor Name Torax Medical Incorporated	NCT Number NCT02429830	IDE Number G160170	CMS Approval Date 2017-06-06	Category B
Study Title Endograft Repair of Thoracoabdominal Aortic Aneurysms (TAAA)	Sponsor Name The Christ Hospital	NCT Number NCT03111459	IDE Number G170036	CMS Approval Date 2017-06-05	Category B
Study Title Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II	Sponsor Name PROCEPT BioRobotics	NCT Number NCT03123250	IDE Number G170027	CMS Approval Date 2017-06-05	Category B
Study Title A Prospective, Randomized, Multi-Center, Open-Label Pilot Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions	Sponsor Name Medtronic Spinal and Biologics	NCT Number NCT03118505	IDE Number G160139	CMS Approval Date 2017-05-26	Category B
Study Title Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial	Sponsor Name Washington University School of Medicine	NCT Number NCT03052920	IDE Number G140244	CMS Approval Date 2017-05-26	Category B
Study Title TECNIS Next-Generation Intraocular Lens, Models ZHR00 and ZQR00	Sponsor Name Abbott Medical Optics Inc.	NCT Number NCT03111550	IDE Number G170055	CMS Approval Date 2017-05-10	Category B
Study Title Corvia Medical Interatrial Shunt Device (IASD) System II	Sponsor Name Corvia Medical, Inc.	NCT Number NCT03088033	IDE Number G150210	CMS Approval Date 2017-05-10	Category B
Study Title Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization	Sponsor Name Rex Medical	NCT Number NCT02961894	IDE Number G160267	CMS Approval Date 2017-05-10	Category B
Study Title Clinical Evaluation of the Cochlear Nucleus(R) CI532 Cochlear Implant in Adults	Sponsor Name Cochlear	NCT Number NCT03007472	IDE Number G160256	CMS Approval Date 2017-05-05	Category B
Study Title Abre Venous Self-Expanding Stent System	Sponsor Name Medtronic	NCT Number NCT03038438	IDE Number G160163	CMS Approval Date 2017-05-03	Category B
Study Title Phase III Study to Compare the Effectiveness of Magnetic Resonance Guided Focused Ultrasound With Computed Tomography Guided Radiofrequency Ablation for Treatment of Osteoid Osteomas	Sponsor Name Matthew Bucknor	NCT Number NCT02923011	IDE Number G160266	CMS Approval Date 2017-05-03	Category B
Study Title Healing Chronic Venous Stasis Wounds With Autologous Cell Therapy	Sponsor Name InGeneron, Inc.	NCT Number NCT02961699	IDE Number BB17214	CMS Approval Date 2017-04-26	Category B
Study Title Aluvra	Sponsor Name Impleo Medical, Inc.	NCT Number NCT03090607	IDE Number G160238	CMS Approval Date 2017-04-24	Category B
Study Title Sapphire II PRO - A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Acute Safety and Device Procedural Success of the Sapphire II PRO 1.0 and 1.25 mm PTCA Dilatation Catheters.	Sponsor Name OrbusNeich	NCT Number NCT03052530	IDE Number G170007	CMS Approval Date 2017-04-24	Category B
Study Title Impact of Fever Prevention in Brain Injured Patients	Sponsor Name C. R. Bard	NCT Number NCT02996266	IDE Number G160108	CMS Approval Date 2017-04-18	Category B
Study Title STOP Persistent AF	Sponsor Name Medtronic Atrial Fibrillation Solutions	NCT Number NCT03012841	IDE Number G160177	CMS Approval Date 2017-04-17	Category B
Study Title Extracorporeal CPR for Refractory Out-of-Hospital Cardiac Arrest (EROCA)	Sponsor Name University of Michigan	NCT Number NCT03065647	IDE Number G160263	CMS Approval Date 2017-04-14	Category B
Study Title Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction to Reduce Infarct Size (DTU): A Prospective Feasibility Study	Sponsor Name ABIOMED	NCT Number NCT03000270	IDE Number G160197	CMS Approval Date 2017-04-14	Category B
Study Title Da Vinci SP Surgical System, Endowrist SP Instruments, and Accessories	Sponsor Name Intuitive Surgical, Inc.	NCT Number NCT03049280	IDE Number G160251	CMS Approval Date 2017-04-04	Category B
Study Title Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)	Sponsor Name University of Minnesota - Clinical and Translational Science Institute	NCT Number NCT02930889	IDE Number G160004	CMS Approval Date 2017-04-03	Category B
Study Title Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia	Sponsor Name University of California, San Diego	NCT Number NCT03055624	IDE Number G160214	CMS Approval Date 2017-03-21	Category B
Study Title Artisse Intrasaccular Device	Sponsor Name Medtronic	NCT Number NCT02998229	IDE Number G160213	CMS Approval Date 2017-03-20	Category B
Study Title IN.PACT AV Access Paclitaxel-Coated PTA Balloon Catheter	Sponsor Name Medtronic Vascular, Inc.	NCT Number NCT03041467	IDE Number G160242	CMS Approval Date 2017-03-20	Category B
Study Title A Multi-Center, Randomized, Pivotal Study Evaluating AMPLEX® Compared To Autogenous Bone Graft in Subjects Indicated for Arthrodesis Surgery Involving the Hindfoot or Ankle	Sponsor Name Ferring Pharmaceuticals	NCT Number NCT03028415	IDE Number G150153	CMS Approval Date 2017-03-15	Category A
Study Title Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms	Sponsor Name BioVentrix	NCT Number NCT02931240	IDE Number G160013	CMS Approval Date 2017-03-09	Category B
Study Title LEADERS FREE II: BioFreedom Pivotal Study	Sponsor Name Biosensors Europe SA	NCT Number NCT02843633	IDE Number G130034	CMS Approval Date 2017-03-07	Category B
Study Title A 3:1 Randomized Trial Comparing the Boston Scientific RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty for the Treatment of Superficial Femoral Arteries (SFA) and Proximal Popliteal Arteries (PPA) – RANGER II SFABoston Scientific Cor...	Sponsor Name Boston Scientific Corp.	NCT Number NCT03064126	IDE Number G160172	CMS Approval Date 2017-03-02	Category B
Study Title A Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS™ System	Sponsor Name Premia Spine	NCT Number NCT03012776	IDE Number G160168	CMS Approval Date 2017-03-02	Category B
Study Title Mitral Valve Repair Clinical Trial (MAVERIC Trial)	Sponsor Name Mvrx, Inc.	NCT Number NCT02302872	IDE Number G160098	CMS Approval Date 2017-02-23	Category A
Study Title MASTER	Sponsor Name GE Healthcare	NCT Number NCT02972892	IDE Number G160132	CMS Approval Date 2017-02-21	Category B
Study Title Gore CARDIOFORM ASD Occluder	Sponsor Name W.L.Gore and Associates, Inc.-GORE®	NCT Number NCT02985684	IDE Number G160218	CMS Approval Date 2017-02-10	Category B
Study Title The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study	Sponsor Name Medtronic Cardiovascular	NCT Number NCT02979587	IDE Number G120175	CMS Approval Date 2017-02-07	Category B
Study Title A Prospective, Multicenter Clinical Trial of the Implantable Miniature Telescope in Pseudophakic Eyes With Central Vision Impairment Associated With End-Stage Macular Degeneration.	Sponsor Name VisionCare, Inc.	NCT Number NCT03011554	IDE Number G160121	CMS Approval Date 2017-02-06	Category B
Study Title A Prospective, Randomized Multicenter Controlled Trial of CERAMENT™\|G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures	Sponsor Name BONESUPPORT	NCT Number NCT02820363	IDE Number G160150	CMS Approval Date 2017-02-01	Category B
Study Title Study of Access Site for Enhancing PCI in STEMI for Seniors (SAFE STEMI for Seniors)	Sponsor Name Duke/ Medtronic/Terumo/Volcano	NCT Number NCT02939976	IDE Number G160113	CMS Approval Date 2017-01-31	Category B
Study Title Ovation Alto Abdominal Stent Graft System	Sponsor Name Endologix, Inc.	NCT Number NCT02949297	IDE Number G160226	CMS Approval Date 2017-01-23	Category B
Study Title Clinical Effectiveness of Conventional Versus Mirasol-treated Apheresis Platelets in Patients With Hypoproliferative Thrombocytopenia	Sponsor Name Terumo BCT Biotechnologies	NCT Number NCT02964325	IDE Number BB16116	CMS Approval Date 2017-01-23	Category B
Study Title Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System	Sponsor Name Edwards Lifesciences	NCT Number NCT02471807	IDE Number G150041	CMS Approval Date 2017-01-11	Category A
Study Title A Traditional Feasibility Study of Gemcitabine, Cisplatin, and 90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma	Sponsor Name Medical University of South Carolina	NCT Number NCT02512692	IDE Number G150096	CMS Approval Date 2017-01-10	Category B
Study Title Phase II Trial Of Optune Plus Bevacizumab In Bevacizumab-Refractory Recurrent Glioblastoma	Sponsor Name NovoCure Ltd.	NCT Number NCT02743078	IDE Number G150275	CMS Approval Date 2017-01-10	Category B
Study Title International Randomized Trial to Evaluate The Effectiveness of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation (OCS Liver PROTECT Trial)	Sponsor Name TransMedics	NCT Number NCT02522871	IDE Number G140192	CMS Approval Date 2016-12-20	Category B
Study Title A Feasibility Study of Sequential Hepatic Internal Radiation and Systemic Ipilimumab and Nivolumab in Patients With Uveal Melanoma Metastatic to Liver.	Sponsor Name David Minor, MD	NCT Number NCT02913417	IDE Number G150186	CMS Approval Date 2016-12-05	Category B
Study Title Tack Optimized Balloon Angioplasty Study for the Below The Knee Arteries Using the Tack Endovascular System®	Sponsor Name Intact Vascular	NCT Number NCT02942966	IDE Number G160144	CMS Approval Date 2016-12-05	Category B
Study Title Safety and Efficacy of Adult Adipose-Derived Stem Cell Injections Into Partial Thickness Rotator Cuff Tears	Sponsor Name InGeneron, Inc.	NCT Number NCT02918136	IDE Number BB16956	CMS Approval Date 2016-12-05	Category B
Study Title A Randomized Trial to Confirm the Safety and Effectiveness of Chocolate Touch™ Paclitaxel Coated Balloon Catheter, in Above the Knee Lesions	Sponsor Name TriReme Medical, LLC	NCT Number NCT02924857	IDE Number G160085	CMS Approval Date 2016-11-23	Category B
Study Title Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH)	Sponsor Name Rhode Island Hospital	NCT Number NCT02676544	IDE Number G150192	CMS Approval Date 2016-11-17	Category B
Study Title Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation (PDN) in Patients With Pulmonary Hypertension - US	Sponsor Name SoniVie Ltd.	NCT Number NCT02835950	IDE Number G160110	CMS Approval Date 2016-11-17	Category A
Study Title Multi-Center, Prospective, Randomized, Controlled Clinical Evaluation of the Safety and Effectiveness of the Sight Sciences VISCO™360 Viscosurgical System in Canaloplasty Versus Selective Laser Trabeculoplasty in the Reduction of IOP in Primary Open Ang...	Sponsor Name Sight Sciences, Inc.	NCT Number NCT02928289	IDE Number G160064	CMS Approval Date 2016-11-08	Category B
Study Title Efficacy and Safety of LifeSeal™ Kit for Staple Line Sealing in Colorectal and Coloanal Anastomoses: A Prospective Randomized Study	Sponsor Name LifeBond Ltd.	NCT Number NCT02907385	IDE Number G150157	CMS Approval Date 2016-11-08	Category B
Study Title Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders and Previously Untreatable Patients, SOLVE CRT	Sponsor Name EBR Systems, Inc.	NCT Number NCT02922036	IDE Number G150244	CMS Approval Date 2016-11-01	Category B
Study Title Closing the Loop on Tremor: A Responsive Deep Brain Stimulator for the Treatment of Essential Tremor	Sponsor Name University of Florida	NCT Number NCT02649166	IDE Number G160053	CMS Approval Date 2016-10-31	Category B
Study Title Pivotal Clinical Study to Evaluate the Safety and Effectiveness of MANTA Vascular Closure Device	Sponsor Name Essential Medical, Inc.	NCT Number NCT02908880	IDE Number G160115	CMS Approval Date 2016-10-25	Category B
Study Title Multi-center, Prospective, Randomized, Controlled Clinical Trial Study of Chronic Tibial Nerve Stimulation (CTNS) to Demonstrate Non-Inferiority in the Treatment of Urinary Urgency Incontinence Resulting From Refractory Overactive Bladder (OAB) With Wirel...	Sponsor Name StimGuard, LLC.	NCT Number NCT02577302	IDE Number G150178	CMS Approval Date 2016-10-19	Category B
Study Title Prospective, Non‐randomized, Single Arm, Multicenter Clinical Evaluation of the INSPIRIS RESILIA Pulmonary Valve (Model 11500P) for Pulmonary Valve Replacement	Sponsor Name Edwards Lifesciences	NCT Number NCT02656290	IDE Number G120108	CMS Approval Date 2016-10-13	Category B
Study Title The WhiteSwell System: WhiteSwell Bloodline, WhiteSwell Console, WhiteSwell Catheter	Sponsor Name Boston Biomedical Associates, LLC.	NCT Number NCT02863796	IDE Number G160083	CMS Approval Date 2016-10-03	Category A
Study Title JetStream Atherectomy for the Treatment of In-stent Restenosis of the Femoropopliteal Artery	Sponsor Name Midwest Cardiovascular Research Foundation	NCT Number NCT02730234	IDE Number G160015	CMS Approval Date 2016-09-19	Category B
Study Title CorMatrix ECM Tricuspid Valve Replacement Safety and Early Feasibility	Sponsor Name CorMatrix	NCT Number NCT02397668	IDE Number G150019	CMS Approval Date 2016-09-15	Category A
Study Title Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) (150kHz) for 1-10 Brain Metastases From Non-small Cell Lung Cancer (NSCLC)	Sponsor Name Novocure	NCT Number NCT02831959	IDE Number G160089	CMS Approval Date 2016-09-12	Category B
Study Title Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness	Sponsor Name Advanced Bionics	NCT Number NCT02189798	IDE Number G140019	CMS Approval Date 2016-09-12	Category B
Study Title Monovisc	Sponsor Name Anika Therapeutics, Incorporated	NCT Number NCT02698865	IDE Number G150131	CMS Approval Date 2016-09-12	Category B
Study Title GDS Accucinch Ventriculoplasty System	Sponsor Name Guided Delivery Systems, Inc.	NCT Number NCT02806570	IDE Number G150249	CMS Approval Date 2016-09-12	Category A
Study Title Investigation of the FAST Sound Coding Strategy in Newly Implanted Adult Cochlear Implant Recipients	Sponsor Name Cochlear Americas	NCT Number NCT02698787	IDE Number G150140	CMS Approval Date 2016-09-01	Category B
Study Title Evaluation of the TULSA-PRO MRI-guided Transurethral Ultrasound Prostate Ablation Device in Patients With Localized Prostate Cancer	Sponsor Name Profound Medical Inc.	NCT Number NCT02766543	IDE Number G130103	CMS Approval Date 2016-08-23	Category B
Study Title A Pilot, Prospective, Randomized, Controlled, Multicenter Technical Feasibility Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant	Sponsor Name Cohera Medical, Inc.	NCT Number NCT02841891	IDE Number G160120	CMS Approval Date 2016-08-23	Category A
Study Title A Pilot Study to Evaluate the Safety and Efficacy of the Hypoglossal Nerve Stimulator in Adolescents and Young Adults With Down Syndrome and Obstructive Sleep Apnea	Sponsor Name Massachusetts Eye and Ear Infirmary	NCT Number NCT02344108	IDE Number G140209	CMS Approval Date 2016-08-16	Category B
Study Title Prospective, Randomized, Controlled, Multicenter, Pivotal, Clinical Investigation Evaluating the Safety and Efficacy of HEMOBLAST Bellows in Cardiothoracic, Abdominal, and Orthopedic Lower Extremity Surgeries	Sponsor Name Biom'Up SA	NCT Number NCT02780869	IDE Number G160063	CMS Approval Date 2016-08-10	Category B
Study Title 13C-Methacetin Breath Test for the Prediction of Outcome in Acute Liver Failure	Sponsor Name William Lee	NCT Number NCT02786836	IDE Number G150226	CMS Approval Date 2016-08-09	Category B4
Study Title Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair	Sponsor Name NeoChord	NCT Number NCT02803957	IDE Number G160067	CMS Approval Date 2016-08-08	Category B2
Study Title Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH SF Catheter Evaluated for Treating Symptomatic Persistent AF (PRECEPT)	Sponsor Name Biosense Webster, Inc	NCT Number NCT02817776	IDE Number G140102	CMS Approval Date 2016-08-03	Category B
Study Title Covera Vascular Covered Stent	Sponsor Name Bard Peripheral Vascular, Inc.	NCT Number NCT02790606	IDE Number G160109	CMS Approval Date 2016-07-22	Category B
Study Title Zoll 731 Series Ventilator with Fio2 Closed-Loop Control (CLC)	Sponsor Name Zoll Medical Corporation	NCT Number NCT02810080	IDE Number G150245	CMS Approval Date 2016-07-22	Category A
Study Title WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures	Sponsor Name Boston Scientific Corporation	NCT Number NCT02802020	IDE Number G150185	CMS Approval Date 2016-07-20	Category B
Study Title State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With Deep Brain Stimulation (DBS)	Sponsor Name University of Minnesota - Clinical and Translational Science Institute	NCT Number NCT02709148	IDE Number G150273	CMS Approval Date 2016-07-15	Category B
Study Title Misago® RX Self-expanding Peripheral Stent for Common and/or External Iliac Artery (OSPREY ILIAC)	Sponsor Name Terumo Medical Corporation	NCT Number NCT02793492	IDE Number G160035	CMS Approval Date 2016-07-13	Category B
Study Title Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD)	Sponsor Name Boston Scientific	NCT Number NCT02787785	IDE Number G160074	CMS Approval Date 2016-07-11	Category B
Study Title Pivotal Study of the MicroVention, Inc. Carotid Artery Stent System Used in Conjunction With the Nanoparasol® Embolic Protection System for the Treatment of Carotid Artery Stenosis in Patients at Elevated Risk for Adverse Events From Carotid Endarterecto...	Sponsor Name Microvention-Terumo, Inc.	NCT Number NCT02657707	IDE Number G140249	CMS Approval Date 2016-07-07	Category B
Study Title One-arm, Multi-center, International Prospective Study to Assess the Efficacy of Medi-Tate Temporary Implantable Nitinol Device (TINDTM) in Subjects With Benign Prostatic Hypertrophy (BPH).	Sponsor Name Medi-tate Ltd	NCT Number NCT02145208	IDE Number G150068	CMS Approval Date 2016-06-29	Category B
Study Title Barostim Neo® - Baroreflex Activation Therapy® for Heart Failure	Sponsor Name CVRx	NCT Number NCT02627196	IDE Number G120010	CMS Approval Date 2016-06-23	Category B
Study Title Intrepid Transcatheter Mitral Valve Replacement System	Sponsor Name Medtronic	NCT Number NCT02322840	IDE Number G160020	CMS Approval Date 2016-06-23	Category A
Study Title Evaluation of WIRION™ EPS in Lower Extremities Arteries	Sponsor Name Gardia Medical, Ltd.	NCT Number NCT02780349	IDE Number G160081	CMS Approval Date 2016-06-23	Category B
Study Title COVERA Vascular Covered Stent	Sponsor Name Bard Peripheral Vascular	NCT Number NCT02649946	IDE Number G160001	CMS Approval Date 2016-06-23	Category B
Study Title A Multicenter Randomized Controlled Trial to Compare the Efficacy of Ex-vivo Normothermic Machine Perfusion With Static Cold Storage in Human Liver Transplantation	Sponsor Name OrganOx, Ltd.	NCT Number NCT02775162	IDE Number G140243	CMS Approval Date 2016-06-09	Category B
Study Title A Randomized, Prospective, Open Label, Multicenter Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Nod...	Sponsor Name NOVADAQ	NCT Number NCT02209532	IDE Number G150254	CMS Approval Date 2016-06-06	Category B
Study Title Caisson Transcatheter Mitral Valve Replacement (TMVR) System	Sponsor Name Caisson Interventional, LLC	NCT Number NCT02768402	IDE Number G160055	CMS Approval Date 2016-06-06	Category A
Study Title Adjunctive Renal Denervation to Modify Hypertension and Sympathetic Tone as Upstream Therapy in the Treatment of Atrial Fibrillation	Sponsor Name Boston Scientific, Vivek Reddy, MD	NCT Number NCT01635998	IDE Number G150161	CMS Approval Date 2016-06-06	Category A
Study Title A Pilot Study to Assess Engraftment Using CliniMACS TCR-α/β and CD19 Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Progenitor Cell Transplantation in Patients With Relapsed Lymphoma	Sponsor Name Peiman Hematti	NCT Number NCT02652468	IDE Number BB16328	CMS Approval Date 2016-05-25	Category B
Study Title Evaluation of the Thoraflex™ Hybrid Device for Use in the Repair or Replacement of the Ascending Aorta, Aortic Arch and Descending Aorta in an Open Surgical Procedure.	Sponsor Name Terumo CVS	NCT Number NCT02724072	IDE Number G150224	CMS Approval Date 2016-05-18	Category B
Study Title Randomized, Multi-Center Pivotal Study for Sacral Nerve Stimulation to Treat Refractory Urgency Urinary Incontinence With Wireless Neuromodulation Technology	Sponsor Name StimGuard	NCT Number NCT02434874	IDE Number G150047	CMS Approval Date 2016-05-18	Category B
Study Title FlowTriever Pulmonary Embolectomy Clinical Study	Sponsor Name Inari Medical	NCT Number NCT02692586	IDE Number G160002	CMS Approval Date 2016-05-17	Category B
Study Title COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV (COMPASSION S3)	Sponsor Name Edwards Lifesciences	NCT Number NCT02744677	IDE Number G150220	CMS Approval Date 2016-05-04	Category B
Study Title A Prospective, Multi Center Pilot Study Evaluating Plaque Photoablation Using the RA-308 Excimer Laser in Subjects With Symptomatic Infrainguinal Lower Extremity Vascular Disease	Sponsor Name Ra Medical Systems	NCT Number NCT02653456	IDE Number G150154	CMS Approval Date 2016-05-04	Category B
Study Title A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction (Athena)	Sponsor Name Mentor Worldwide	NCT Number NCT02724371	IDE Number G150173	CMS Approval Date 2016-04-18	Category B
Study Title Self-Centering Guide Catheter Feasibility Study	Sponsor Name Boston Scientific Corporation	NCT Number NCT02639494	IDE Number G150260	CMS Approval Date 2016-04-13	Category B
Study Title Silver Nitrate-Coated Indwelling Pleural Catheter (SNCIPC)	Sponsor Name CareFusion, Inc.	NCT Number NCT02649894	IDE Number G150146 S001	CMS Approval Date 2016-04-13	Category A
Study Title REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients (RESCUE)	Sponsor Name Mt. Sinai	NCT Number NCT01747837	IDE Number G150050	CMS Approval Date 2016-04-12	Category A
Study Title Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation	Sponsor Name Mitralign, Inc.	NCT Number NCT02574650	IDE Number G150170	CMS Approval Date 2016-04-12	Category A
Study Title Analysis of Prostatic Arterial Embolization for Benign Prostatic Hyperplasia Using Embosphere Microspheres	Sponsor Name Sergei Sobolevsky	NCT Number NCT02679430	IDE Number G140130	CMS Approval Date 2016-04-05	Category B
Study Title A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness and Safety of CELSTAT as an Adjunct to Hemostasis for Tissue Bleeding in Cardiothoracic, General, and Vascular Surgery.	Sponsor Name Baxter Healthcare Corporation	NCT Number NCT02640235	IDE Number G130173	CMS Approval Date 2016-04-05	Category B
Study Title Clinical Study of the BreathID® System to train the algorithm for the ¹³C-Octanoate Breath Test with or without the ¹³C-Methacetin Breath Test (OBT and MBT respectively) for correlation with histological findings of Non-Alcoholic Fatty Liver Disease ...	Sponsor Name Exalenz Bioscience	NCT Number NCT02314026	IDE Number G140254	CMS Approval Date 2016-03-17	Category B
Study Title Valiant Evo US Clinical Trial	Sponsor Name Medtronic	NCT Number NCT02652949	IDE Number G150251	CMS Approval Date 2016-03-09	Category B
Study Title Evaluation of Extended Infusion Set Wear Using the Medtronic Extended Wear Sof-set Infusion Set	Sponsor Name Stanford University	NCT Number NCT02687256	IDE Number G150256	CMS Approval Date 2016-03-08	Category A
Study Title CyberHeart's Cardiac Arrhythmia Ablation Treatment: Patients With Refractory Ventricular Tachycardia/Fibrillation	Sponsor Name CyberHeart Inc.	NCT Number NCT02661048	IDE Number G130270	CMS Approval Date 2016-02-29	Category A
Study Title The CarboClear Pedicle Screw System	Sponsor Name Carbo-Fix Orthopedics Inc.	NCT Number NCT02626624	IDE Number G150139	CMS Approval Date 2016-02-26	Category B
Study Title Use of The Spanner Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men	Sponsor Name SRS Medical	NCT Number NCT02643849	IDE Number G150243	CMS Approval Date 2016-02-16	Category B
Study Title The BARD® VENOVO ™ Venous Stent Study – A Prospective, Non-Randomized, Multi-Center, Single-Arm Study of the Treatment of Iliofemoral Occlusive Disease – an Assessment for Effectiveness and Safety (VERNACULAR)	Sponsor Name Bard Peripheral Vascular	NCT Number NCT02655887	IDE Number G150248	CMS Approval Date 2016-02-09	Category B
Study Title SSO2 therapy: IC-HOT study a multi-center evaluation of the delivery of intracoronary hyperoxemic supersaturated oxygen therapy for 60 minutes in anterior acute myocardial infarction patients with successful reperfusion (via PCI) ≤ six hours after sympt...	Sponsor Name TherOx, Inc	NCT Number NCT02603835	IDE Number G120029	CMS Approval Date 2016-02-04	Category A
Study Title Randomized Trial of COBRA PzF Stenting to Reduce Duration of Triple Therapy (COBRA-REDUCE)	Sponsor Name CeloNova BioSciences, Inc.	NCT Number NCT02594501	IDE Number G130190	CMS Approval Date 2016-01-25	Category B
Study Title Endovascular Repair of Descending ThoracoAbdominal Aortic Pathologies Using Physician Modified Endovascular Prosthesis	Sponsor Name Rodney A. White, M.D.	NCT Number NCT02524834	IDE Number G150087	CMS Approval Date 2016-01-20	Category B
Study Title REDUCE LAP-HF Randomized Trial I	Sponsor Name Corvia Medical, Inc.	NCT Number NCT02600234	IDE Number G150210	CMS Approval Date 2016-01-13	Category B
Study Title Efficacy and Safety of an Active Pulsed Electromagnetic Field for the Treatment of Osteoarthritis of the Knee	Sponsor Name Orthofix Inc.	NCT Number NCT02436590	IDE Number G140251	CMS Approval Date 2015-12-30	Category B
Study Title Focal Electrically-Administered Seizure Therapy (FEAST) Studies at Two Enrolling Sites to Further Test and Refine the Treatment	Sponsor Name Medical University of South Carolina	NCT Number NCT02535572	IDE Number G150034	CMS Approval Date 2015-12-30	Category B
Study Title EVOLVE Short DAPT Study	Sponsor Name Boston Scientific Corporation	NCT Number NCT02605447	IDE Number G150194	CMS Approval Date 2015-12-18	Category B
Study Title Clinical Evaluation of a Vascular Anastomotic Connector System for Minimally Invasive Connection of an Arteriovenous Graft for Hemodialysis	Sponsor Name Phraxis, Inc.	NCT Number NCT02532621	IDE Number G140221	CMS Approval Date 2015-12-15	Category B
Study Title Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3	Sponsor Name Gregory W Albers	NCT Number NCT02586415	IDE Number G150028	CMS Approval Date 2015-12-04	Category B
Study Title Critical Limb Ischemia Rapid Delivery by SurgWerks-CLI Kit and VXP System (CLIRST III)	Sponsor Name Cesca Therapeutics, Inc.	NCT Number NCT02538978	IDE Number BB16266	CMS Approval Date 2015-11-24	Category B
Study Title Prostate Artery Embolization Safety and Efficacy: A Pilot Study	Sponsor Name University of Virginia	NCT Number NCT02592473	IDE Number G150021	CMS Approval Date 2015-11-24	Category B
Study Title Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy in Patients With Post Myocardial Infarction Heart Failure (CardiAMP Heart Failure Trial)	Sponsor Name BioCardia, Inc.	NCT Number NCT02438306	IDE Number BB16057	CMS Approval Date 2015-11-18	Category B
Study Title CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery	Sponsor Name CytoSorbents, Inc	NCT Number NCT02566525	IDE Number G140256	CMS Approval Date 2015-11-12	Category B
Study Title Electrical Nerve Stimulation of the Ulnar Nerve During Cubital Tunnel Decompression Surgery: Does it Improve Long Term Functional Outcomes?	Sponsor Name University of Chicago	NCT Number NCT02566616	IDE Number G150054	CMS Approval Date 2015-11-10	Category B
Study Title A Randomized Trial Comparing the ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent for Treatment of Superficial Femoral and/or Proximal Popliteal Arteries	Sponsor Name Boston Scientific Corporation	NCT Number NCT02574481	IDE Number G150171	CMS Approval Date 2015-10-28	Category B
Study Title aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibrillation	Sponsor Name SentreHEART, Inc.	NCT Number NCT02513797	IDE Number G150107	CMS Approval Date 2015-09-29	Category B
Study Title A Clinical Evaluation of the Safety of the St. Jude Medical Quartet 1457Q Left Ventricular Lead, an Investigational Device Exemption (IDE) Study	Sponsor Name St. Jude Medical	NCT Number NCT02548455	IDE Number G150175	CMS Approval Date 2015-09-29	Category B
Study Title The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant)	Sponsor Name Active Implants	NCT Number NCT02483988	IDE Number G150052	CMS Approval Date 2015-09-28	Category B
Study Title Pyrocarbon IDE Study	Sponsor Name Tornier, Inc.	NCT Number NCT02525783	IDE Number G140202	CMS Approval Date 2015-09-23	Category B
Study Title A Prospective, Multi-Center, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions	Sponsor Name Nitiloop Ltd.	NCT Number NCT02477579	IDE Number G150032	CMS Approval Date 2015-09-23	Category B
Study Title Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries (TOBA II)	Sponsor Name Intact Vascular	NCT Number NCT02522884	IDE Number G150029	CMS Approval Date 2015-09-23	Category B
Study Title Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads	Sponsor Name Biotronik SE & Co. KG	NCT Number NCT02290028	IDE Number G150147	CMS Approval Date 2015-09-21	Category B
Study Title Analysis of Revascularization in Ischemic Stroke with EmboTrap® (ARISE II).	Sponsor Name Neuravi® Inc.,	NCT Number NCT02488915	IDE Number G140253	CMS Approval Date 2015-08-17	Category B
Study Title Coronary InterventionS in HIgh-Risk PatiEnts Using a Novel Percutaneous Left Ventricular Support Device (SHIELD II)	Sponsor Name Thoratec Corporation	NCT Number NCT02468778	IDE Number G150079	CMS Approval Date 2015-08-17	Category B
Study Title Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms	Sponsor Name W.L.Gore & Associates	NCT Number NCT02489539	IDE Number G150057	CMS Approval Date 2015-08-05	Category B
Study Title Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens	Sponsor Name Lenstec Incorporated	NCT Number NCT02487160	IDE Number G140134	CMS Approval Date 2015-07-28	Category B
Study Title Phase II, Single Center, Single Arm, Open Label Investigation of Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams	Sponsor Name South Florida Medical Imaging, PA	NCT Number NCT02396420	IDE Number G140213	CMS Approval Date 2015-07-28	Category B
Study Title Medtronic Resolute Onyx Core (2.25 mm - 4.0 mm) Clinical Study	Sponsor Name Medtronic Vascular	NCT Number NCT02419521	IDE Number G140178	CMS Approval Date 2015-07-02	Category B
Study Title Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System (MIMICS-2)	Sponsor Name Veryan Medical Ltd.	NCT Number NCT02400905	IDE Number G140182	CMS Approval Date 2015-06-29	Category B
Study Title Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae	Sponsor Name C. R. Bard	NCT Number NCT02440022	IDE Number G150067	CMS Approval Date 2015-06-17	Category B
Study Title The Asahi Intecc PTCA Chronic Total Occlusion Study	Sponsor Name Asahi Intecc USA Inc	NCT Number NCT02379923	IDE Number G150007	CMS Approval Date 2015-06-04	Category B
Study Title Resolute Onyx 2.0 mm Clinical Study - A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent	Sponsor Name Medtronic Vascular	NCT Number NCT02412501	IDE Number G140178	CMS Approval Date 2015-05-14	Category B
Study Title Zenith® p-Branch® Pivotal Study	Sponsor Name Cook Incorporated	NCT Number NCT02396199	IDE Number G120136	CMS Approval Date 2015-05-06	Category B
Study Title A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components	Sponsor Name Cerus Corporation	NCT Number NCT0230573	IDE Number BB6200	CMS Approval Date 2015-05-05	Category B
Study Title Endurant Evo US Clinical Trial	Sponsor Name Medtronic Endovascular	NCT Number NCT02393716	IDE Number G150024	CMS Approval Date 2015-04-17	Category B
Study Title Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions (BIOFLOW-V)	Sponsor Name Biotronik, Inc.	NCT Number NCT02389946	IDE Number G140078	CMS Approval Date 2015-04-17	Category B
Study Title Safety and Effectiveness of the Treatment of Wide Neck, Intracranial, Saccular Aneurysms With the Next Generation Neuroform Stent System	Sponsor Name STRYKER	NCT Number NCT02340585	IDE Number G150006	CMS Approval Date 2015-04-14	Category B
Study Title Evaluation of the Technical Success of IVUS Guided VCF Placement Using the LUMIFI™ With Crux® VCF System	Sponsor Name Volcano Corporation	NCT Number NCT02394912	IDE Number G140194	CMS Approval Date 2015-04-01	Category B
Study Title HARMONEE - Japan-USA Harmonized Assessment by Randomized, Multi-Center Study of OrbusNEich's Combo StEnt	Sponsor Name OrbusNeich	NCT Number NCT02073565	IDE Number G140118	CMS Approval Date 2015-04-01	Category B

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