The FDA trial will be known as The MASTER II (MGuard™ for Acute ST Elevation Reperfusion), the second in a series of clinical studies intended to both validate the effectiveness of the MGuard™ EPS platform, as well as achieve registration with the appropriate regulatory authorities worldwide.
InspireMD's MGuard™ EPS technology previously yielded positive results in the MASTER I findings, which 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 the survival of patients suffering from acute myocardial infarction.
About InspireMD's MGuard™ EPS Technology
In stroke and acute heart attack patients, the plaque or thrombus is unstable and often breaks up as a stent is implanted causing downstream blockages, some of which can be fatal, in a significant portion of heart attack patients.
The MGuard™ EPS stent system is integrated with a precisely engineered micro net mesh designed to prevent the unstable arterial plaque and thrombus (clots) that cause these blockages from breaking off. The mesh is designed to provide outstanding and lifelong embolic protection, without affecting deliverability. MGuard™ EPS is CE Mark approved. MGuard™ EPS, however, is not approved for sale in the U.S. by the FDA.
About InspireMD, Inc.
InspireMD is a medical device company focusing on the development and commercialization of its proprietary stent system technology, MGuard™. InspireMD intends to pursue applications of this technology in coronary, carotid and peripheral artery procedures. InspireMD's common stock is quoted on the NYSE MKT under the ticker symbol NSPR.
|SOURCE InspireMD, Inc.|
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