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May 14, 2026
IDE Approved for Pivotal Study of InspireMD’s SwitchGuard Neuro Protection System
KEY TAKEAWAYS
- FDA approves IDE for CGUARDIANS III pivotal study of InspireMD’s SwitchGuard neuroprotection system.
- The study will evaluate SwitchGuard for use with the CGuard Prime 80-cm stent platform in transcarotid artery revascularization procedures.
- Patrick Geraghty, MD, and Patrick Muck, MD, will serve as Colead Investigators for the CGUARDIANS III trial.
May 14, 2026—InspireMD, Inc., developer of the CGuard Prime carotid stent system for the prevention of stroke, announced that the FDA has approved the company’s investigational device exemption (IDE) application to initiate the CGUARDIANS III pivotal study.
According to InspireMD, the study will evaluate the company’s SwitchGuard neuroprotection system, including next-generation enhancements from the previous IDE approval for use with InspireMD’s CGuard Prime 80-cm stent platform, in transcarotid artery revascularization procedures.
Patrick Geraghty, MD, and Patrick Muck, MD, will serve as Colead Investigators for the CGUARDIANS III trial. They previously coled the CGUARDIANS II trial.
Dr. Geraghty is 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.
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