InspireMD has reported positive clinical results from an investigator-sponsored MIcrovascular Coronary Flow Comparison in Acute Myocardial Infarction Angioplasty (MICAMI) MGuard trial.
The controlled trial enrolled forty patients with ST-elevation myocardial infarction (STEMI) patients, at three centers in Chile, who were randomized to receive either MGuard or traditional bare metal stents (BMS) stents.
MGuard features a coronary stent which is wrapped with an an ultra-thin polymer micron net, thus providing lifelong embolic protection, without affecting deliverability.
The study was designed to investigate whether the use of MGuard could reduce distal embolization of thrombus/platelet aggregates and improve coronary and myocardial reperfusion.
The study demonstrated that the STEMI patients who underwent coronary angioplasty with MGuard exhibited statistically significant improvement in microvascular reperfusion criteria.
MICAMI trial lead investigator Dante Lindefjeld said every perfusion parameter measured in their study displayed superior outcomes in the MGuard group compared to the BMS group.
"Additional randomized trials are now appropriate to gather more data about the role of MGuard in clinical use," Lindefjeld said.
InspireMD Research and Development CTO and vice president Eli Bar said they will continue to study MGuard to generate further data about its safety and efficacy.