InspireMD, Inc., the developer of the MGuard™ Embolic Protection Stent (EPS), has announced approval with conditions for its US FDA Investigational Device Exemption (IDE) application. 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.
To the best of our knowledge the MGuard EPS stent system is the only such device to feature the combination of stent integrated with a micro net mesh designed to prevent the unstable arterial plaque and thrombus (clots) that cause these blockages from breaking off. The mesh is designed to provide outstanding and lifelong embolic protection, without affecting deliverability.
We’ve covered the company before, last August relaying the news that the MASTER I study was complete. That study revealed a statistically and clinically significant acute advantage of MGuard™ EPS with regard to ST segment resolution. As a result it seems the device may hold the potential to lower the incidence of adverse events and prolong the survival of patients suffering from acute myocardial infarction.
Back then the company was expecting to be announcing the IDE study by year end. Now it seems the pivotal study is ready to start with FDA issuing a conditional IDE aproval for the study. 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 vessel myocardial 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).
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.
“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.”
MGuard™ EPS is CE Mark approved. MGuard™ EPS, however, is not approved for sale in the U.S. by the FDA.
Source: Inspire MD, Inc., PR Newswire