InspireMD starts key study of CGuard Prime in TCAR surgeries

InspireMD is moving along on its exciting journey to potentially getting the CGuard Prime Carotid Stent System approved by the FDA for use in trans carotid artery revascularization (TCAR) procedures. The very first patient had the honor of being enrolled at Good Samaritan Hospital in Cincinnati, Ohio, by the study’s co-lead investigator, Dr. Patrick Muck.

This pivotal study, CGUARDIANS II, will look at how well the CGuard Prime system performs, teamed with an FDA-cleared TCAR neuroprotection device, in these high-risk patients needing carotid endarterectomy. There’s a hope that this system will secure FDA approval with a CAS indication by the first half of next year. And CEO Marvin Slosman has shown support, recognizing the study’s importance to the TCAR market.

The trial stands on the shoulders of success from prior data and real-world use of the CGuard platform. A victory here could give InspireMD a significant boost and open doors for the company in the U.S. TCAR market. Dr. Muck shared his enthusiasm for the study, highlighting the safety benefits offered by CGuard Prime’s technology, particularly thanks to its MicroNet mesh.

Back in October, InspireMD snagged an investigational device exemption (IDE) from the FDA for the CGuard Prime carotid stent system. This device, designed to prevent stroke, had already secured CE mark approval earlier this year. These are all steps toward making this innovative system a reality for patients.