InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced the company has received CE Mark approval under the European Medical Device Regulation (MDR) for the CGuard® Prime EPS.
CGuard® Prime was developed incorporating extensive user feedback and optimizes deliverability and deployment of the proven CGuard stent. With its proprietary MicroNet™ mesh, CGuard is designed to reduce both early and late embolic events by trapping debris against the vessel wall, preventing plaque prolapse and embolization that can cause stroke.
“Securing CE Mark certification under the EU MDR is a major milestone that demonstrates InspireMD’s commitment to advancing our next-generation platforms, regulatory rigor, and execution,” said Marvin Slosman, CEO of InspireMD. “This approval clears the path for the commercial launch of CGuard® Prime EPS across our current CE marked served markets, taking a pivotal step forward in our growth as a commercial-stage company and further strengthening our leadership in carotid stenting innovation. Additionally, this is the same platform that we intend to launch in the United States later this year, subject to FDA approval, enabling greater scale as we move towards offering a unified platform across our served markets.”
