InspireMD Announces Positive Results from iMOS Prime Registry for the MGuard Prime EPS
Study of 97 patients resulted in zero mortalities in STEMI patients as of 30-day follow up
Results to be presented at EuroPCR meeting in Paris on Thursday, May 22nd at 4:50 p.m. CEST
BOSTON, /PRNewswire/ -- InspireMD, Inc. ("InspireMD" or the "Company"), a leader in embolic protection stents (EPS), today 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 (PCI) 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 PCI. 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 EPS performance," stated Dr. 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 (MACE) at 30 days, the primary endpoint for the study. MACE is defined as the composite of cardiac death, myocardial infarction (Q wave and non-Q wave) or target lesion revascularization (PTCA or CABG).
"The MGuard Prime's performance in the iMOS Prime Registry is consistent with our previous STEMI studies, reinforcing our belief that the MGuard Prime may offer superior mortality benefits compared to other stents on the market," stated Alan Milinazzo, President and Chief Executive Officer of InspireMD. "Further, during this study, there was a 100% success rate reported in the delivery and deployment of the MGuard Prime."
The MGuard Prime utilizes the Company's proprietary MicroNet™ technology, which is a circular knitted mesh that wraps around a cobalt chromium stent to protect patients from plaque debris flowing downstream upon deployment. This advanced technology allows the MGuard Prime to specifically address the unmet need for STEMI patients, and save the life of those who suffer from heart attacks.
Source: InspireMD, Inc.
InspireMD Announces Positive Results from iMOS Prime Registry for the MGuard Prime EPS
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