InspireMD has announced new results from the iMOS (International MGuard Observational Study) Prime registry demonstrating that use of the MGuard Prime in cases of acute ST-segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention resulted in complete ST-resolution in approximately 75% of cases, and a 2.2% rate of major adverse cardiac events (MACE) at 30 days, including zero cases of mortality.
The iMOS Prime registry evaluated the ’real world’ clinical performance of the MGuard Prime coronary stent system in patients with acute STEMI undergoing percutaneous coronary intervention. Between December 13 2012 and March 19 2014, there were 97 patients with STEMI enrolled at two sites in the Netherlands.
“I have treated many patients with coronary disease requiring a thrombus management solution over the years and I am excited to share results from the recently completed iMOS Prime registry in a real world setting which looked at the MGuard Prime embolic protection system performance,” states Giovanni Amoroso, interventional cardiologist at OLVG Hospital in The Netherlands. “This iMOS registry is the first study done exclusively with the lower profile MGuard Prime embolic protection system. I am happy to report that device success was achieved in 100% of all cases. In addition, TIMI 3 flow was achieved 92% of the time, complete ST-resolution was achieved in approximately 75% of the cases, and finally, 30 day all-cause mortality was 0%. We plan to continue to follow the patients out to 12 months.”
The iMOS Prime registry achieved a 2.2% rate of major adverse cardiac events rate at 30 days, the primary endpoint for the study.