QualityStocks would like to highlight InspireMD (OTCBB: NSPR), 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.
In the company’s news yesterday,
InspireMD said that it has completed enrollment in its MASTER (MGuard™ for Acute ST Elevation Reperfusion) trial testing its stent platform technology for use in patients with Acute Myocardial Infarctions. The completion of enrollment has been achieved one month ahead of schedule, according to the company.
The MASTER Trial is a multinational randomized controlled trial being conducted in 50 centers across nine countries (Germany, Hungary, Israel, Poland, Czech Republic, France, Ireland, Brazil, and South Africa) 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. The trial 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 company is on track to release preliminary top line results in the third quarter of 2012.
One week ago, the InspireMD reported positive three-year results from the extended follow-up MAGICAL trial, a prospective, single arm, multi-center study conducted in 2008-09 that enrolled 60 STEMI patients, at a company-sponsored symposium at the EuroPCR conference in Paris. In that report, the company detailed that the safety and efficacy of MGuard™ observed in the trial were maintained for three years.
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