InspireMD Receives CE Mark Approval for Carotid Embolic Protection Stent

March 15, 2013—InspireMD, Inc. (Tel Aviv, Israel) announced that the company received CE Mark approval for its self-expanding nitinol carotid embolic protection stent (EPS). The carotid EPS device is based on the company's MicroNet mesh protection platform technology that is also used for the treatment of myocardial infarction patients in InspireMD's commercially available coronary MGuard and MGuard Prime EPS devices.

According to the company's press release, the InspireMD carotid EPS is wrapped with a MicroNet mesh to prevent embolic events during and after carotid artery stent procedure. The MicroNet is designed to hold plaque and thrombus in place against the wall of the blocked artery, preventing debris from falling into the bloodstream and causing a potentially fatal downstream blockage or stroke.

In markets that recognize the CE Mark, the new InspireMD carotid EPS stent will be available in a matrix of sizes ranging from small diameters of 5 X 20 mm to large diameters up to 10 X 60 mm for large carotid arteries. MGuard is not approved for sale in the United States.

The company notes that in coronary procedures, InspireMD's EPS technology has shown improvements through the MASTER trial findings that revealed a statistically and clinically significant acute advantage of MGuard EPS with regard to ST segment resolution. InspireMD's coronary EPS is CE Mark approved.