The European Union has granted CE mark certification to InspireMD’s Nitinol carotid embolic protection stent (EPS), which is designed to offer procedural and post-procedural distal embolic protection in carotid artery stenting (CAS) procedures, and reduce risk of stroke events.
The self-expanding system will be available in a matrix of sizes ranging from small diameters of 5mm x 20mm to large diametres up to 10mm x 60mm for large carotid arteries.
The system uses the company’s MicroNet mesh protection platform technology that holds plaque and thrombus against the wall of the blocked artery and prevents debris from falling into the bloodstream and causing a potentially fatal downstream blockage or stroke.
The technology is also being used in the company’s coronary EPS stents, including MGuard and MGuard Prime to treat heart attack patients.
During the company’s MASTER trial, the technology has shown to improve ST segment resolution while performing coronary procedures using MGuard EPS.
As a result, MGuard EPS may hold the potential to lower the incidence of adverse events and prolong survival of heart attack victims, according to the company.
InspireMD president and CEO Alan Milinazzo said the company is looking forward to accelerate its clinical development programme with the carotid system.
"The CE mark should enhance our partnership strategy in the near term," Milinazzo said.