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 607 entries
Study Title Sponsor Name NCT Number IDE Number CMS Approval Date Category
Symplicity Spyral Renal Denervation System Medtronic NCT05116384 G220017 2023-03-16 A
Phase 2 Trial of Ablative MRI-guided Stereotactic Body Radiation Therapy and Tumor Treating Fields for Locally Advanced Pancreas Cancer Baptist Health South Florida NCT05679674 G220281 2023-03-16 A
Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone Cavities Elute, Inc. NCT05361941 G210130 2023-02-17 B
DART 2.0: ctHPV-DNA Informed De-Escalated Adjuvant and Definitive Radiation Therapy Mayo Clinic NCT05541016 G220182 2023-02-17 B
Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Iliofemoral Venous Obstruction W.L.Gore & Associates NCT05489588 G220169 2023-01-19 B
A Multicenter, Prospective, Randomized, Controlled, Open Label Trial to Evaluate the Safety and Efficacy of Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression in Patients Who Have Undergone Endovascular Procedures Utilizing up to 12F Procedural Sheaths Cordis Corporation NCT05554471 G220147 2023-01-12 B
REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT), a Phase I Prospective Randomized Controlled Trial Inova Health Care Services NCT05652218 G220157 2023-01-12 B
A Single-Arm, Single-Center, Non-Randomized, Prospective Clinical Study to Evaluate the Safety and Effectiveness of Physician Modified Endograft for Complex Abdominal and Thoracoabdominal Aortic Aneurysm Repair University of California, San Diego NCT05339061 G220057 2023-01-12 B
Remote Ischemic PreConditioning Provides Neuroprotection: A Phase 2, Single Center, Randomized, Double-Blind, Sham-Controlled, Safety and Efficacy Study Evaluating the Use of Remote Ischemic Preconditioning in Patients Undergoing Endovascular Repair of Brain Aneurysms Sebastian Koch NCT03814850 G180220 2023-01-05 B
Evaluation of Spinal Cord Ischemia and Mortality and Morbidity After Endovascular Repair of Pararenal and Thoracoabdominal Aortic Aneurysm Using Surgeon-Modified Endografts Konstantinos Arnaoutakis NCT05195905 G210245 2022-12-29 B
Page Last Modified:
12/01/2021 07:02 PM