InspireMD has received approval for its investigational device exemption (IDE) application from the US Food and Drug Administration (FDA) to initiate MASTER II clinical study of its MGuard embolic protection stent (EPS).
The CE-marked device, which is integrated with a micro net mesh, prevents the unstable arterial plaque and thrombus (clots) that cause the blockages from breaking off.
The multi-center, randomized study will enroll 1,114 patients with ST Elevation Myocardial Infarction (STEMI) to validate the safety and effectiveness of MGuard EPS and compare both bare metal and drug eluting stents.
The study's co-primary endpoints include superiority in complete ST resolution and non-inferiority in death and target vessel myocardial infarction.
InspireMD CEO and president Alan Milinazzo said the trial will validate the safety and effectiveness of MGuard EPS and compare both bare metal and drug eluting stents.
During the company's previous MASTER I trial, the MGuard EPS technology reported a statistically and clinically significant acute advantage of MGuard EPS with regard to ST segment resolution.
In addition, the company will conduct a 356 patient sub-study to assess the effect of MGuard EPS on vessel infarct size, as measured through cardiac magnetic resonance imaging (MRI).
The trial will also support the company's application to market its MGuard Prime MicroNet covered coronary stent system in the US.