InspireMD wins CE Mark approval for CGuard Prime

InspireMD today announced it received CE Mark approval for its CGuard Prime carotid stent system for the prevention of stroke.

The Miami-based company said the next-generation carotid stent system was developed based on physician feedback and features improved deliverability and deployment. It builds on the original CGuard design, which uses a proprietary MicroNet mesh to reduce the risk of stroke by trapping embolic debris and preventing plaque prolapse.

“Securing CE Mark certification under the EU MDR is a major milestone that demonstrates InspireMD’s commitment to advancing our next-generation platforms, regulatory rigor, and execution,” CEO Marvin Slosman said in a news release.

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