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 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
Study Title Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia	Sponsor Name Medtronic Cardiac Ablation Solutions	NCT Number NCT06703489	IDE Number G240240	CMS Approval Date 2025-02-26	Category B
Study Title PELE IDE Clinical Study, Peripheral Onyx™ Liquid Embolic Safety and Effectiveness of The Onyx™ LES for Embolization of Arterial Hemorrhage in the Peripheral Vasculature	Sponsor Name Medtronic Endovascular	NCT Number NCT06742801	IDE Number G240276	CMS Approval Date 2025-02-25	Category B
Study Title A Randomized Controlled Study of the Prevail Drug-Coated Balloon in Subjects With In-stent Restenosis and a Single Arm Prospectively Enrolled Study of the Prevail Drug-Coated Balloon for de Novo Lesions in Small Vessel Disease (Prevail Global)	Sponsor Name Medtronic Vascular	NCT Number NCT06535854	IDE Number G240209	CMS Approval Date 2025-02-25	Category B
Study Title PARADIGM Study: Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System	Sponsor Name EndoQuest Robotics, Inc.	NCT Number NCT06133387	IDE Number G240271	CMS Approval Date 2025-02-15	Category B
Study Title PARADIGM Study: Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System	Sponsor Name EndoQuest Robotics, Inc.	NCT Number NCT06133387	IDE Number G240271	CMS Approval Date 2025-02-14	Category B
Study Title Feasibility Study to Evaluate the Initial Safety and Effectiveness of TRUFILL n-BCA Liquid Embolic System in Middle Meningeal Artery Embolization for the Preventive Treatment of Refractory Chronic Migraine	Sponsor Name Cerenovus, Part of DePuy Synthes Products, Inc.	NCT Number NCT06735833	IDE Number G230327	CMS Approval Date 2025-01-28	Category B

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