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April 23, 2013 /PRNewswire/ --
InspireMD, Inc. (NYSE MKT: NSPR) ("Inspire" or the "Company"), the developer of the MGuard™ Embolic Protection Stent (EPS), announced today that on
April 19, 2013, the Company received an approval with conditions for its Investigational Device Exemption (IDE) application with the U.S. Food and Drug Administration (FDA). An approval with conditions indicates that the FDA concurs with the overall trial design and while minor details are being finalized, allows the company to initiate enrollment in the MASTER II IDE trial.
The multi-center, randomized trial will consist of 1,114 patients suffering from ST Elevation Myocardial Infarction (STEMI), throughout 35 sites in the U.S. and an additional 35 sites in
Europe, and will support the Company's application to market its MGuard™ Prime MicroNet™ covered coronary stent system in the US.
Gregg Stone M.D., of The Cardiovascular Research Foundation, and
Jose P. S. Henriques M.D., of the Academic Medical Center Amsterdam in
the Netherlands, will serve as Principal Investigators for the trial, which will consist of two co-primary endpoints: superiority in complete ST resolution and non-inferiority in death and target vesselmyocardial infarction. In addition, a 356 patient sub-study will be conducted to assess the effect of MGuard™ EPS on vessel infarct size, as measured through cardiac Magnetic Resonance Imaging (MRI).
"Receiving this approval to commence our FDA trial is a significant milestone." commented
Alan Milinazzo, InspireMD's CEO and President. Mr. Milinazzo further noted, that "This trial will provide an excellent opportunity to validate the safety and effectiveness of MGuard™ EPS in another large multi-center, randomized trial, comparing both bare metal and drug eluting stents, the current therapy for STEMI patients."
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.