InspireMD receives CE mark for Carotid Embolic Protection Stent


InspireMD is the developer of the MGuard Embolic Protection Stent and announced on 15 March 2013 that the company received CE mark approval for its self-expanding Nitinol carotid Embolic Protection Stent. This carotid embolic protection stent is based on the proprietary MicroNetmesh protection platform technology used to treat myocardial infarction patients with InspireMD’s commercially available coronary Embolic Protection Stent stents, MGuard and MGuard Prime.  

When treating carotid arterial disease, close to half of carotid artery stenting procedures cause distal embolic events that may lead to stroke within 30 days, according to InspireMD. The InspireMD Carotid Embolic Protection Stent is wrapped with a MicroNetmesh to prevent embolic events during and post carotid artery stenting 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 coronary procedures, InspireMD’s Embolic Protection Stent technology has already shown improvements through the MASTER trial findings that revealed a statistically and clinically significant acute advantage of MGuard Embolic Protection Stent with regard to ST segment resolution. As a result, MGuard Embolic Protection Stent may hold the potential to lower the incidence of adverse events and prolong survival of heart attack victims. The new InspireMD Carotid Embolic Protection Stent will be available in a matrix of sizes ranging from small diameters of 5x20mm to large diameters up to 10x60mm for large carotid arteries.

InspireMD’s president and CEO, Alan Milinazzo, commented: “The CE mark approval for our MGuard carotid system is a major milestone for the company and is further validation of the Micronet technology. We look forward to accelerating our clinical development programme with our carotid system. The CE mark should enhance our partnership strategy in the near term.”

InspireMD’s Embolic Protection Stent technology

The InspireMD Embolic Protection Stent system technology is integrated with a precisely engineered micro net mesh that prevents the unstable arterial plaque and thrombus that caused the blockage from breaking off. The embolic protection is comprised of an ultra-thin polymer micron net that is integrated with the stent. The mesh is designed to provide outstanding and lifelong embolic protection, without affecting deliverability. MGuard Embolic Protection Stent is CE mark approved. InspireMD’s Coronary Embolic Protection Stent is also CE mark approved. MGuard is not approved for sale in the USA by the US Food and Drug Administration.