InspireMD announced today the launch of a multinational randomized controlled trial designed to demonstrate MGuard Coronary Stent’s superiority over standard care for STEMI (heart attack) patients.
The MASTER (MGUARD for Acute ST Elevation Reperfusion) Randomized Trial will enroll 406 patients in a 2-arm, parallel design, with a primary endpoint of complete ST segment resolution post procedure. Clinical follow-up will continue for 1 year and other important secondary endpoints will be measured. Dr. Gregg Stone, Director of Cardiovascular Research and Education from the Columbia University in New-York, who will serve as a study chairman, said “Too often primary PCI in patients with heart attack results in suboptimal blood flow to the heart muscle, resulting in excessive heart damage. We are hopeful that this trial will demonstrate that the MGuard technology improves the success rate of PCI and clinical outcomes in patients with heart attacks.”
Mr. Ofir Paz, CEO of InspireMD said “The initiation of this trial is a very important milestone in our continuous effort to supply compelling evidence based information on MGuard to the cardiology community. We are committed to pursue our clinical program and demonstrate MGuard superiority over standard care.”
The trial will run in Europe, South America and Israel with principal investigators, Dr. Alexandre Abizaid, Dr. Dariusz Dudek and Prof. Chaim Lotan.
About MGuard Coronary
MGuard presents a novel combination of a coronary stent merged with an embolic protection specifically designed for Acute MI patients. The embolic protection is comprised of an ultra-thin polymer mesh sleeve that wraps the stent. The MGuard coronary stent provides permanent embolic protection, without affecting deliverability. MGuard is CE Mark approved. The MGuard Coronary’s innovative concept has enjoyed an enthusiastic welcome from leading interventional cardiologists around the world.
About InspireMD (www.inspire-md.com)
InspireMD is an innovative medical device company focusing on the development and commercialization of its proprietary stent system technology, MGuard. The company intends to apply its technology to develop products used in interventional cardiology and other vascular procedures. InspireMD’s mission is to utilize its proprietary technology to make its products the industry standard for stents and to provide a superior solution to the key clinical issues of current stenting: restenosis, embolic showers, and late thrombosis. In addition to providing embolic protection and minimizing arterial injury, this promising technology can be an effective and uniform drug delivery mechanism with the help of the novel micron-level net for next generation drug eluting stents. InspireMD intends to pursue applications of this technology both for bare metal and drug eluting stents in coronary, carotid and peripheral artery procedures.