InspireMD Announces FDA Approval of CGUARDIANS III Study for SwitchGuard Neuro Protection System
InspireMD Inc. has received FDA approval for its Investigational Device Exemption application to start the CGUARDIANS III pivotal study of the SwitchGuard neuro protection system, aimed at enhancing stroke prevention in transcarotid artery revascularization procedures. The study will leverage the CGuard Prime 80 cm stent platform and aims for a commercial launch in 2027, pending results and approvals.
MIAMI, May 01, 2026 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced that the U.S. Food and Drug Administration (“FDA”) has approved the company’s Investigational Device Exemption (“IDE”) Application to initiate the CGUARDIANS III pivotal study of its SwitchGuard neuro protection system (“NPS”), including next generation enhancements from our prior IDE approval for use with its CGuard Prime 80 cm stent platform, in transcarotid artery revascularization (“TCAR”) procedures.