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June 16, 2025
InspireMD CGuard Prime EPS Carotid Stent System Receives CE Mark Approval
June 16, 2025—InspireMD, Inc. recently announced it has received CE Mark approval under the European Medical Device Regulation (EU MDR) for the CGuard Prime embolic protection system (EPS), a MicroNet mesh-covered carotid stent intended to widen narrowed carotid arteries in patients at high risk for surgery.
According to InspireMD, CGuard Prime EPS is designed to reduce both early and late embolic events by trapping debris against the vessel wall, preventing plaque prolapse and embolization.
The company advised that the EU MDR approval allows for the commercial launch of CGuard Prime EPS across its current CE Mark–served markets.
The company intends to launch the platform in the United States later in 2025, subject to FDA approval, noted the press release.
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