NSPR News .70 InspireMD Announces Enrollment Co
Post# of 144482
NSPR News .70
InspireMD Announces Enrollment Completion In Master Trial
2012-05-24 08:00 ET - News Release
Milestone Reached in MGuard™ Clinical Development, Results Expected 3Q 2012
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.