InspireMD's Carotid Embolic Protection Stent is designed to provide procedural, post-procedural distal embolic protection in CAS procedures.
InspireMD Inc., the company behind the development of the MGuard Embolic Protection Stent (EPS), received CE mark approval for its self-expanding Nitinol carotid EPS. This carotid embolic protection stent is based on the proprietary MicroNet mesh protection platform technology used to treat heart attack patients with InspireMD's commercially available coronary EPS stents, MGuard, and MGuard Prime.
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 mesh to prevent embolic events during and post CAS 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 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 5mm x 20mm to large diameters up to 10mm x 60mm for large carotid arteries.
Commenting on the approvals, InspireMD's President and CEO, Alan Milinazzo, says, “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.”
About InspireMD's EPS Technology
In stroke and acute heart attack patients, the plaque or thrombus is unstable and often breaks up as the stent is implanted causing downstream blockages (some of which can be fatal) in a significant portion of heart attack patients.
The InspireMD EPS stent system technology is integrated with a precisely engineered micro net mesh that prevents the unstable arterial plaque and thrombus (clots) 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 EPS is CE Mark approved. InspireMD's Coronary EPS is now CE Mark approved. MGuard is not approved for sale in the U.S. by the U.S. Food and Drug Administration.