InspireMD's MGuard Prime EPS Evaluated in iMOS Prime Registry

May 7, 2014—InspireMD, Inc. announced results from the iMOS (International MGuard Observational Study) Prime Registry, which is evaluating the use of the company’s MGuard Prime embolic protection system (EPS) in acute ST-segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI). The iMOS data will also be presented on May 22 at the EuroPCR conference in Paris, France.

According to InspireMD, the iMOS data showed that use of the MGuard Prime resulted in complete ST resolution in approximately 75% of cases and a 2.2% rate of major adverse cardiac events (MACE) at 30 days (the study’s primary endpoint), including zero cases of mortality. MACE is defined as the composite of cardiac death, myocardial infarction (Q wave and non-Q wave), or target lesion revascularization (angioplasty or surgery).

The iMOS Prime Registry evaluated the real-world clinical performance of the MGuard Prime system in 97 patients with acute STEMI undergoing PCI between December 13, 2012, and March 19, 2014, at two sites in the Netherlands.

Giovanni Amoroso, MD, interventional cardiologist at OLVG Hospital in the Netherlands, discussed the study in the company’s press release. Dr. Amoroso commented, “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. This iMOS registry is the first study done exclusively with the lower-profile MGuard Prime EPS. 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.” 

On April 30, InspireMD announced that it had initiated a voluntary field action following recent reports of stent dislodgements with the company’s MGuard Prime EPS.