Medical device company InspireMD, Inc. (NASDAQ:NSPR) announced on Friday that it has received CE Mark certification under the European Medical Device Regulation (MDR) for its CGuard Prime Embolic Prevention System (EPS), a carotid stent designed to prevent stroke.

The CGuard Prime incorporates user-driven enhancements to improve device deliverability and deployment, while maintaining the core design of the original CGuard system. Its proprietary MicroNet mesh technology is engineered to minimise embolic events by trapping arterial debris and preventing plaque prolapse and embolisation.

The approval paves the way for the commercial launch of CGuard Prime EPS within CE-marked markets, while aligning with InspireMD's strategy to expand into the United States, pending FDA approval later this year.

CGuard EPS is targeted at patients at high surgical risk, offering a less invasive solution with sustained embolic protection. Long-term results have demonstrated effectiveness beyond five years.