TEL-AVIV, Israel, March 15, 2013 /PRNewswire/ — InspireMD, Inc. (OTC BB: NSPR) (“Inspire” or the “Company”), the developer of the MGuard™ Embolic Protection Stent (EPS), announced today that the Company received CE mark approval this morning for its self-expanding Nitinol carotid EPS. This carotid embolic protection stent is based on the proprietary MicroNet[TM] mesh protection platform technology used to treat heart attack patients with InspireMD’s commercially available coronary EPS stents, MGuard[TM] and MGuard Prime[TM].
When treating carotid arterial disease, close to half of Carotid Artery Stenting (CAS) procedures cause distal embolic events that may lead to stroke within 30 days. The InspireMD Carotid Embolic Protection Stent (EPS) is wrapped with a MicroNet[TM] mesh to prevent embolic events during and post CAS procedure. The MicroNet[TM] 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 EPS technology has already 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. As a result, MGuard EPS may hold the potential to lower the incidence of adverse events and prolong survival of heart attack victims. The new InspireMD Carotid EPS 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.
Commenting on today’s approvals, 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 program with our carotid system. The CE mark should enhance our partnership strategy in the near term.”