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 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 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
Study Title A Randomized Controlled Trial Evaluating Safety When Using the 3M™ AbThera™ Open Abdomen Negative Pressure Therapy System with Instillation and Dwell Time in the Management of the Open Abdomen	Sponsor Name Solventum	NCT Number NCT06658015	IDE Number G220263	CMS Approval Date 2025-03-17	Category B
Study Title The Pivotal Study of RapidPulseTM Aspiration System as Frontline Approach for Patient With Acute Ischemic Stroke Due to Large Vessel Occlusions	Sponsor Name RapidPulse, Inc	NCT Number NCT06029491	IDE Number G240031	CMS Approval Date 2025-03-17	Category B
Study Title Clinical Outcomes and Predictors of Major Adverse Events in Patients Treated for Juxtarenal, Pararenal and Thoracoabdominal Aortic Aneurysms with Physician-Modified Fenestrated and Branched Stent Grafts	Sponsor Name Mayo Clinic	NCT Number NCT06526676	IDE Number G230305	CMS Approval Date 2025-03-17	Category B
Study Title Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE)	Sponsor Name Bolt Medical	NCT Number NCT06181240	IDE Number G240193	CMS Approval Date 2025-03-11	Category B
Study Title Blood Purification for the Treatment of Critically Ill Patients With Pathogen Associated Shock: A Multicenter, Randomized Controlled Feasibility Trial	Sponsor Name ExThera Medical Corporation	NCT Number NCT05011656	IDE Number G210074	CMS Approval Date 2025-03-11	Category A
Study Title Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms	Sponsor Name Cleveland Clinic	NCT Number NCT06657794	IDE Number G240233	CMS Approval Date 2025-03-04	Category B
Study Title Peripheral-5 CTO Crossing System (PER-5)	Sponsor Name AngioSafe	NCT Number NCT06737978	IDE Number G240260	CMS Approval Date 2025-02-27	Category B

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