CGuard® Prime Embolic Prevention System (EPS)

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InspireMD Announces CE Mark Approval for CGuard® Prime Embolic Prevention System (EPS) Under European MDR for the Prevention of Stroke
GlobeNewswire News Room· 2025-06-13 13:00
Core Points - InspireMD, Inc. has received CE Mark approval for the CGuard® Prime EPS under the European Medical Device Regulation, marking a significant milestone for the company [1][3] - The CGuard® Prime system is designed to enhance deliverability and deployment while reducing embolic events through its proprietary MicroNet™ mesh technology [2][4] - The approval paves the way for commercial launch in CE marked markets and is expected to facilitate a U.S. launch later this year, pending FDA approval [3] Company Overview - InspireMD aims to establish its MicroNet™ technology as the industry standard for carotid stenting, focusing on acute results and long-term stroke-free outcomes [5] - The CGuard Embolic Prevention System is designed for patients at high risk for surgical complications, offering a less invasive treatment option [4] - InspireMD's common stock is traded on Nasdaq under the ticker symbol NSPR, and the company actively shares important investor information on its website [5]