InspireMD, Inc. announced on June 13, 2025, that it received CE Mark approval under the European Medical Device Regulation (MDR) for its CGuard Prime Embolic Prevention System (EPS). This approval is a major milestone, demonstrating the company's commitment to advancing its next-generation platforms and regulatory rigor.
The CE Mark clears the path for the commercial launch of CGuard Prime EPS across InspireMD's current CE marked served markets. This strengthens the company's leadership in carotid stenting innovation and represents a pivotal step forward in its growth as a commercial-stage company.
CGuard Prime, with its proprietary MicroNet mesh, is designed to reduce early and late embolic events by trapping debris and preventing plaque prolapse. This is the same platform that InspireMD intends to launch in the United States, subject to FDA approval, enabling greater scale and a unified platform across its markets.
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