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TEL AVIV, Israel,
May 24, 2012 /PRNewswire/ -- InspireMD, Inc. (OTC BB: NSPR) (the "Company" or "InspireMD"), a medical device company focusing on the development and commercialization of its proprietary stent platform technology for use in patients with Acute Myocardial Infarctions, today announced that is has completed enrollment in the MASTER (MGuard™ for Acute ST Elevation Reperfusion) trial. The Company is on track to release preliminary top line results in the third quarter of 2012.
Eli Bar, CTO and Vice President of Research and Development of InspireMD, commented: "This is an important milestone in the clinical development of MGuard™. The timely completion of enrollment has been achieved one month ahead of schedule. Completion of the MASTER trial is a key component of our plan to establish MGuard™ as the standard of care for Acute MI patients."
The MASTER Trial is a multinational randomized controlled trial designed to evaluate the MGuard™ and MGuard Prime Coronary Stents compared with the standard of care, bare metal stents (BMS) or drug eluting stents (DES), for acute ST-elevation myocardial infarction (STEMI) patients. It has enrolled 432 patients in a two-arm, parallel design study. The primary endpoint is complete ST segment resolution. Clinical follow-up will continue for one year and important secondary endpoints such as TIMI (Thrombolysis In Myocardial Infarction) flow, MBG (Myocardial Blush Grade) and MACE (Major Adverse Cardiac Events) will be measured. Sub-studies include infarct size measured by cardiac MRI, as well as restenosis by invasive angiographic follow-up at 13 months.
The MASTER Trial is being conducted in 50 centers in nine countries:
France, Ireland, Brazil and
South Africa. Dr.
Gregg Stone, Director of Cardiovascular Research and Education,
Columbia University in
New York, is the study chairman. The trial's principal investigators are Prof.
Alexandre Abizaid of the Institute Dante Pazzanese de Cardiologia in
Sao Paulo Brazil; Prof.
Dariusz Dudek from Jagiellonian University in Krakow,
Poland; and Prof.
Sigmund Silber of University of
Munich, Germany. Detailed results from the trial are expected to be submitted for presentations at interventional cardiology meetings in the second half of the year.
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 listed on the OTC BB under the ticker symbol "NSPR".