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.

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Study Title	Sponsor Name	NCT Number	IDE Number	CMS Approval Date	Category
Study Title CRD_1077 Coronary Intravascular Lithotripsy (IVL) IDE Study	Sponsor Name Abbott Medical Devices	NCT Number NCT06885177	IDE Number G250039	CMS Approval Date 2025-04-08	Category B
Study Title Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention (SAVE-O2 AI)	Sponsor Name University of Colorado, Denver	NCT Number NCT06374225	IDE Number G230325	CMS Approval Date 2025-04-08	Category A
Study Title BIOTRONIK - A Prospective Multicenter Single Arm Study to Assess the SaFety and Effectiveness of the Orsiro Mission 48-mm SiroLimus-Eluting Coronary Stent System for the Treatment Of Subjects With Atherosclerotic Lesion(s)	Sponsor Name Biotronik, Inc.	NCT Number NCT06779630	IDE Number G240288	CMS Approval Date 2025-04-03	Category B
Study Title Function and Speed of Transection Recovery After Therapeutic Electrostimulation of Nerves	Sponsor Name Checkpoint Surgical Inc.	NCT Number NCT06867185	IDE Number G240316	CMS Approval Date 2025-04-03	Category B
Study Title A Pilot Study of Transseptal ECMO With the Protek Solo Cannula in Lung Transplant Candidates With Right Heart Failure From Pulmonary Hypertension	Sponsor Name Mayo Clinic	NCT Number NCT06770023	IDE Number G230225	CMS Approval Date 2025-04-02	Category B
Study Title Safety and Effectiveness of the Akura Thrombectomy System for Use in the Removal of Emboli From the Pulmonary Arteries in Treating Acute Pulmonary Embolism (PE)	Sponsor Name Akura Medical	NCT Number NCT06672510	IDE Number G240074	CMS Approval Date 2025-04-02	Category B
Study Title Study to Evaluate the Safety and Effectiveness of Voyager's Access Device for Patients Undergoing Routine Hemodialysis (Access Cannulation Trial II)	Sponsor Name Voyager Biomedical	NCT Number NCT05490225	IDE Number G240174	CMS Approval Date 2025-04-02	Category B
Study Title A Prospective, Multicenter, Randomized Clinical Investigation Evaluating the Safety and Efficacy of ETHIZIA™ Versus SURGICEL® Original in Controlling Minimal, Mild, or Moderate Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic, Thorac...	Sponsor Name Ethicon, Inc.	NCT Number NCT06664788	IDE Number G240131	CMS Approval Date 2025-04-02	Category A
Study Title An Early Feasibility Study to Evaluate the Safety of the TheraSphere Prostate Cancer (PCa) Device in Patients With Clinically Localized Prostate Cancer	Sponsor Name Boston Scientific Corporation	NCT Number NCT06192758	IDE Number G220299	CMS Approval Date 2025-03-26	Category B
Study Title Chronic Total Occlusion (CTO) Crossing, Re-entry and Imaging with the Acolyte™ Catheter System in Subjects Undergoing Percutaneous Coronary Interventional (PCI) Procedures	Sponsor Name Simpson Interventions, Inc.	NCT Number NCT06795763	IDE Number G240283	CMS Approval Date 2025-03-25	Category B

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