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