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.
Slosman also said that the same platform is expected to launch in the U.S. later this year, pending FDA approval.
InspireMD designed the CGuard system for patients at high risk of surgery who require a less invasive option for treating narrowed carotid arteries. The device pairs an open-cell frame with a fine-pore mesh to provide embolic protection during and after the procedure. InspireMD stated that the design has demonstrated lasting protection for over five years.
