InspireMD, Inc. (Nasdaq: NSPR), a global developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease (CAD) and stroke prevention, today announced that its CGuard EPS stent system has received a positive opinion from the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDIMTS) of the French National Authority for Health (HAS) regarding reimbursement in France, and the CGuard EPS is being added to the list of reimbursed medical products (LPPR) effective October 25, 2021.

This was the final step to full commercial launch of CGuard EPS following CNEDIMTS’ positive opinion for reimbursement received by the Company on May 11, 2021 for the treatment of symptomatic and non-symptomatic lesions when surgery is not indicated.

The CGuard® EPS Self-Expanding Carotid Stent is the latest generation open-cell nitinol self-expanding stent with patented MicroNet® mesh technology designed to prevent the risk of early and late embolism.

“This milestone now provides physicians in France with the choice to use CGuard EPS in the treatment of carotid artery disease and stroke prevention. We strive to improve the standard of care in the treatment of carotid artery disease, by moving away from surgical endarterectomy towards less invasive options such as the CGuard EPS Carotid Stent System. We believe that the unique and proprietary design of our system, is the most advanced and safest stent system on the market today,” said Marvin Slosman, CEO of InspireMD.

Andrea Tommasoli, Senior VP Global Sales and Marketing commented, “We worked closely with HAS for over a year to gain reimbursement approval, and its opinion validated the efficacy and safety of use of the CGuard EPS carotid stent based on our unmatched and expanding portfolio of clinical evidence and the results of our extensive clinical research program. The expansion of CGuard into France represents further progress in our efforts to grow the geographic reach of our commercial products as we continue to establish CGuard as the carotid device of choice among physicians across the world that treat carotid disease.”

The CGuard® carotid stent, is commercially established in 33 markets to date, adding France to our growing global expansion.

Source: Company Press Release