InspireMD has reported the top-line clinical results from an investigator-sponsored controlled randomised trial of MGuard conducted in Chile.
CE-marked MGuard features a novel combination of a coronary stent with an embolic protection specifically designed for use in acute Myocardial Infarctions (MI) patients, providing outstanding and lifelong embolic protection, without affecting deliverability.
Lead investigator Dante Lindefjeld conducted the study known as the microvascular coronary flow comparison in acute myocardial infarction angioplasty (MICAMI) MGuard trial to assess if use of the MGuard could reduce distal embolisation of thrombus / platelet aggregates and thereby improve coronary and myocardial reperfusion in ST-elevation myocardial infarction (STEMI) patients.
The MICAMI trial enrolled 40 patients with STEMI referred for primary PCI at three centres in Chile and were randomised to receive either MGuard or bare metal stents (BMS) treatment.
The study showed that acute STEMI patients who underwent coronary angioplasty with MGuard demonstrated considerable improvement in microvascular reperfusion criteria compared with those treated with traditional BMS. The endpoints of the study included TIMI flow grade, myocardial blush grade, TIMI frame count and the percentage of patients with optimal results.
The trial also demonstrated that 18 patients in the MGuard group achieved Blush grade three compared with ten patients in the BMS group, and 17 patients in the MGuard group achieved successful angioplasty compared with only six in the BMS group.
InspireMD Research and Development chief technology officer and vice president Eli Bar said the results of the 40-patient study add to the growing body of data about MGuard's efficacy, and they will continue to study MGuard to produce further data regarding its safety and efficacy.
MGuard is also being investigated in the 432-patient multicentre international MGuard for acute ST elevation reperfusion (MASTER) trial to investigate the MGuard stent versus commercially-approved BMS or DES products in STEMI patients undergoing primary angioplasty. The results of the MASTER trial are anticipated in the second half of 2012.
Image: MGuard coronary stent has demonstrated significant improvement in microvascular reperfusion in ST-elevation myocardial infarction patients.