InspireMD Enrolls First Patient in the MASTER (MGuard for Acute ST Elevation Reperfusion) Randomized Trial MASTER Trial, chaired by Dr. Gregg Stone from Columbia University, will enroll 432 patients
TEL AVIV, Israel, July 26, 2011 /PRNewswire/ -- InspireMD, Inc. (OTC BB: NSPR) ("Inspire" or the "Company"), the developer of the MGuard™ mesh protective stent system, announced today that the first patient has been enrolled in the MASTER (MGuard for Acute ST Elevation Reperfusion) Randomized Trial, a multinational randomized controlled trial designed to demonstrate MGuard Coronary Stent's superiority over standard care for STEMI (heart attack) patients. The patient was enrolled in the Department of Haemodynamics and Angiocardiography, headed by Dr. Krystrof Zmudka, at the Krakow Specialist Hospital - John Paul II in Krakow, Poland.
The MASTER Randomized Trial will enroll 432 patients in a two-arm, parallel design, with the objective to demonstrate superiority of the MGuard™ stent over commercially-approved bare-metal stents (BMS) or drug-eluting stents (DES) in achieving better myocardial reperfusion in primary angioplasty for the treatment of acute ST-elevation myocardial infarction (STEMI). The primary endpoint is complete ST segment resolution. Clinical follow-up will continue for one year and other important secondary endpoints such as TIMI flow, myocardial blush grade and MACE (major adverse cardiac events) rate will be measured. Sub studies for cardiac MRI and invasive angiography are planned as well. Dr. Gregg Stone, Director of Cardiovascular Research and Education from Columbia University in New York, is the study chairman.
Mr. Eli Bar, CTO and Vice President of Research and Development of InspireMD, commented, "The enrollment of the first patient in the MASTER Trial is a significant milestone for InspireMD. Previous non-randomized trials have demonstrated the safety and efficacy of MGuard in heart attack patients. The importance of the MASTER Trial is validation of these results, in a large, randomized trial. I am confident that the successful completion of the MASTER Trial will be an important step towards making MGuard the standard of care in treatment of heart attack patients."
The MASTER randomized trial will be carried out in 50 centers throughout Brazil, Canada, Czech Republic, France, Germany, Hungary, Israel, Poland and South Africa. The trial's principal investigators are Dr. Alexandre Abizaid, Dr. Dariusz Dudek and Prof. Sigmund Silber.
About MGuard™ Coronary Stent
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 micron net that wraps the stent. The MGuard™ stent provides outstanding and lifelong embolic protection, without affecting deliverability. MGuard™ is CE Mark approved. Mesh-based protection is now recommended for use in the recent Guidelines of the Task force of Myocardial Revascularization of the European Society of Cardiology (ESC).
About InspireMD Inc.
InspireMD is an innovative 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 is traded on the over-the-counter bulletin board (OTC BB) under the ticker symbol "NSPR".
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