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.


Showing 1-10 of 472 entries
Study Title Sponsor Name NCT Number IDE Number CMS Approval Date Category
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 Sirtex Medical NCT04736121 G200352 2021-05-05 B
Human Factors Actual-Use Confirmatory Validation Study of the Eximis CS (Contained Segmentation) System ("Contain" Study) Eximis Surgical NCT04799210 G200318 2021-05-04 B
Proton Particle Therapy for Cardiac Arrhythmia Extracorporeal Energy Source Ablation of Cardiac Tissue: A First Stage Early Feasibility Study Douglas L. Packer, MD NCT04392193 G200015 2021-04-22 B
Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility Study Emory University NCT04714216 G200280 2021-04-22 B
GRAVITY: Genicular Artery Embolization Versus Observation for the Treatment of Symptomatic Knee Osteoarthritis: a Randomized Controlled Trial University of California, Los Angeles NCT04682652 G200303 2021-04-22 B
Cochlear Implant With Dexamethasone Eluting Electrode Array (The CI-DEX Study): Pivotal Study Cochlear NCT04750642 G200098 2021-04-22 B
B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair Eric Roselli, M. D. NCT04747626 G200342 2021-04-16 B
Early Feasibility EXperience of Posterior Leaflet RestOration to REduce Functional Mitral Regurgitation (EXPLORE FMR) Polares Medical SA NCT04666467 G200063 2021-04-16 A
Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms With Physician-Modified Fenestrated and Branched Stent Grafts University of Southern California NCT04524247 G200159 2021-04-16 B
Early Feasibility EXperience of Posterior Leaflet RestOration to REduce Degenerative Mitral Regurgitation (EXPLORE DMR) Polares Medical SA NCT04666480 G200063 2021-04-16 A
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08/04/2015 10:27 AM