InspireMD has completed patient enrolment in the MGuard for Acute ST Elevation Reperfusion (MASTER) trial, designed to evaluate MGuard and MGuard Prime coronary stents.
MGuard is wrapped with an expandable MicroNet (mesh) made of a single knitted polyethylene terephthalate fibre and is attached to the proximal and distal edges of the stent.
During stenting, the MicroNet expands seamlessly and releases emboli into the circulation, resulting in lower blush and reduced risk of plaque rupture and embolisation, providing double protection during and post procedure.
The MASTER trial is a multinational, two-arm, parallel design, randomised controlled study intended to demonstrate the efficacy of MGuard and MGuard Prime coronary stents in 432 patients with acute ST-elevation myocardial infarction (STEMI), when compared to the standard of care with bare metal stents (BMS) or drug eluting stents (DES).
The primary endpoint is complete ST segment resolution and secondary endpoints include thrombolysis in myocardial infarction (TIMI) flow, myocardial blush grade (MBG) and major adverse cardiac events (MACE).
The trial is being conducted in 50 centres across nine countries: Germany, Hungary, Israel, Poland, the Czech Republic, France, Ireland, Brazil and South Africa.
InspireMD research and development chief technology officer and vice president, Eli Bar, said: "Completion of the MASTER trial is a key component in our plan to establish MGuard as the standard of care for Acute MI patients."
The findings from the study are expected to be announced in the third quarter of 2012, at interventional cardiology meetings.
InspireMD is focused on the development and commercialisation of its stent system technology, MGuard, and plans to pursue applications of the technology in coronary, carotid and peripheral artery procedures.