InspireMD, a medical device company, has reported positive results from the iMOS (International MGuard Observational Study) Prime Registry for the MGuard Prime embolic protection stent system (EPS).
The iMOS Prime Registry has showed that the use of the MGuard Prime coronary stent system in acute ST-segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI) resulted in complete ST-resolution in approximately 75% of cases.
The prime registry achieved a 2.2% rate of major adverse cardiac events, which is the primary endpoint for the study, at 30 days. The 30 day all-cause mortality was 0%.
The iMOS Prime Registry assessed the real world clinical performance of the MGuard Prime system in patients with acute STEMI undergoing PCI. A total of 97 STEMI patients were enrolled between 13 December 2012 and 19 March 2014 at two sites in the Netherlands.
InspireMD president and CEO Alan Milinazzo noted that the MGuard Prime’s performance in the iMOS Prime Registry is consistent with the company’s previous STEMI studies, reinforcing its belief that the MGuard Prime may offer superior mortality benefits compared to other stents on the market.
"Further, during this study, there was a 100% success rate reported in the delivery and deployment of the MGuard Prime," Milinazzo added.
Utilizing InspireMD’s MicroNet technology, the MGuard Prime can specifically address the unmet need for STEMI patients and save the life of those who suffer from heart attacks. MicroNet is a circular knitted mesh that wraps around a cobalt chromium stent to protect patients from plaque debris flowing downstream upon deployment.
InspireMD will present results at the EuroPCR meeting in Paris on 22 May 2014.