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 321 entries
Study Title Sponsor Name NCT Number IDE Number CMS Approval Date Category
iCLAS™ for Persistent Atrial Fibrillation Adagio Medical NCT04061603 G180263 2019-10-30 B
Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory West Virginia University NCT03950492 G190011 2019-10-30 B
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 Endotronix, Inc. NCT04089059 G190020 2019-10-30 B
Alfapump® System in the Treatment of Refractory or Recurrent Ascites: a Multicenter Single Arm Within Subject Crossover Design Pivotal Study (the POSEIDON Study) Sequana Medical N.V. NCT03973866 G140126 2019-10-09 B
A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND) Micro Medical Solution, Inc. NCT04025008 G170126 2019-10-02 B
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) Centinel Spine NCT04012996 G190041 2019-09-19 B
CorMatrix Cor TRICUSPID ECM Valve Replacement Safety and Early Feasibility CorMatrix Cardiovascular, Inc. NCT02397668 G180240 2019-09-04 A
Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial Abiomed Inc. NCT03947619 G160197 2019-09-04 B
Exploring the Effects of Spinal Cord Stimulation in Parkinson's Disease Nora Vanegas-Arroyave NCT03526991 G180057 2019-08-23 B
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 Episurf Medical Inc. NCT04000659 G180145 2019-08-23 B
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08/04/2015 02:27 PM