InspireMD Inc., a developer of medical devices for stroke prevention, has announced that it has received CE Mark approval under the European Medical Device Regulation $(MDR.AU)$ for its CGuard® Prime Embolic Prevention System $(EPS)$. This approval is a significant milestone for the company, enabling the commercial launch of CGuard™ Prime EPS across its current CE marked markets in Europe. The CGuard Prime® system, which incorporates user feedback to enhance deliverability and deployment, features a proprietary MicroNet™ mesh designed to reduce embolic events. With this approval, InspireMD is poised to expand its leadership in carotid stenting innovation and plans to launch the platform in the United States later this year, pending FDA approval.
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