October 7, 2024

InspireMD Earns IDE Approval for CGUARDIANS II Pivotal Study

October 7, 2024—InspireMD, Inc., developer of the CGuard embolic prevention stent system for the prevention of stroke, announced that the FDA has approved the company’s application for an investigational device exemption (IDE) to initiate the CGUARDIANS II pivotal study of the company’s CGuard Prime 80-cm carotid stent system during TCAR (transcarotid artery revascularization) procedures.

In February 2024, InspireMD announced that Patrick Geraghty, MD, and Patrick Muck, MD, would act as lead investigators for the trial. Dr. Geraghty is a professor of surgery and radiology, section of vascular surgery at Washington University School of Medicine in St. Louis, Missouri. Dr. Muck is Program Director and Chief of Vascular Surgery at Good Samaritan Hospital in Cincinnati, Ohio.

Subscribe to our weekly newsletter.

Stay informed on the week's top stories including literature summaries, device approvals, guideline changes, and more. Plus, get our latest issues & supplements delivered to your inbox each month.

October 7, 2024

InspireMD Earns IDE Approval for CGUARDIANS II Pivotal Study

Current Issue

Keep In Touch