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 550 entries
Study Title Sponsor Name NCT Number IDE Number CMS Approval Date Category
Stage 2B of: A Pivotal, Prospective, Three-Stage, Single-Arm Study of Focal Ablation of the Prostate With NanoTherm® Therapy System for a Limited-Volume, Clinically Localized, Intermediate-Risk Prostate Cancer MagForce USA NCT05010759 G150104 2022-05-04 B
A Prospective, Randomized, Controlled, Interventional Clinical Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical MonoPoint® Reperfusion System for Aspiration Embolectomy in Acute Ischemic Stroke Patients (SUMMIT MAX) Route 92 Medical, Inc. NCT05018650 G210002 2022-05-04 B
Prospective, Multi-center, Randomized Trial of the Protect PNS for Refractory Overactive Bladder (OAB) – “GUARDIAN” Study Micron Medical Corporation NCT04589507 G200227 2022-04-28 B
The SEAL TO HEAL Study: Study to EvALuate Time TO HEmostasis of AbsorbaSeaL CyndRx NCT05234749 G210374 2022-04-07 B
A Randomized Cross-Over Trial of Deep Brain Stimulation (DBS) of the Posterior Subthalamic Area (PSA), Ventral Intermediate Nucleus of the Thalamus (VIM), and VIM+PSA on Essential Tremor (ET) St. Joseph's Hospital and Medical Center, Phoenix NCT05096572 G210238 2022-04-07 B
Use of the Impella ECP in Patients Undergoing an Elective High-Risk Percutaneous Coronary Intervention: An Early Feasibility Study Abiomed Inc. NCT04477603 G200126 2022-03-23 B
A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating Bilateral-Subthalamic Nucleus Deep Brain Stimulation in Subjects with Early Stage Parkinson’s Disease VUMC NCT01984151 G050016 2022-03-23 B
A Prospective, Multi-Center, Open-Label Assessment of Efficacy and Safety of Quanta SC+ for Home Hemodialysis Quanta Dialysis Technologies Ltd NCT04975880 G200362 2022-03-17 B
Early Feasibility Study of the Vivasure PerQseal®+ (PerQseal® Plus) Vascular Closure Device when used to Achieve Hemostasis of Common Femoral Arteriotomies Created by 14 to 22 F Sheaths in Patients Undergoing Percutaneous Transcatheter Procedures Vivasure NCT05163548 G210227 2022-03-17 B
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) - FASTR Trial Reprieve Cardiovascular, Inc NCT05174312 G210258 2022-03-17 B
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12/01/2021 07:02 PM