The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) to InspireMD to initiate a multi-centre, randomised clinical study of its MGuard embolic protection stent (EPS).
Integrated with a micro net mesh, the CE-marked device prevents unstable arterial plaque and thrombus (clots) from breaking off and causing blockages, which can occur when a stent is implanted.
The mesh is also expected to provide lifelong embolic protection, without affecting deliverability.
The study named, MASTER II, will enrol 1,114 patients with ST Elevation Myocardial Infarction (STEMI) throughout 35 sites in the US and an additional 35 sites in Europe.
Superiority in complete ST resolution and non-inferiority in death and target vessel myocardial infarction are the two co-primary endpoints of the study.
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 with regards to ST segment resolution.
As a result, MGuard EPS may hold the potential to lower the incidence of adverse events and prolong the survival of patients suffering from acute myocardial infarction, according to the company.
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.