November 13, 2013 — InspireMD Inc., a developer of embolic protection stents, announced 12-month results from the MGuard for Acute ST Elevation Reperfusion (MASTER) trial demonstrating that the MGuard outperformed bare metal and drug-eluting stents in all-cause mortality in ST segment elevation myocardial infarction (STEMI) patients. Results from the trial were presented at the Transcatheter Cardiovascular Therapeutics Conference (TCT 2013) in San Francisco.
The MGuard utilizes the InspireMD's proprietary MicroNet technology, which is a circular knitted mesh that wraps around the stent to protect patients from plaque debris flowing downstream upon deployment. This technology allows the MGuard to specifically address the unmet need for ST segment elevation myocardial infarction (STEMI) patients and save the life of those who suffer from heart attacks.
The MASTER trial achieved its primary endpoint (p = 0.008) in complete ST-segment resolution at 60-90 minutes post-procedure. Secondary endpoint clinical outcomes continued to show a lower mortality rate with the MGuard EPS (embolic protection stent) compared to the control (1 percent versus 3.3 percent, p = 0.092) at 12 months. These findings are in line with the previously announced six-month follow-up results showing that all-cause mortality with MGuard EPS was lower than bare metal and drug-eluting stents used as a control (0.5 percent versus 2.8 percent, p = 0.056). Additional 12-month results are available on InspireMD’s website.
"This data further supports the evidence that positive acute results at the time the patient is treated are associated with improved outcomes at 12 months,” said Alan Milinazzo, president and CEO, InspireMD. “Additionally and importantly, the subset data we released on treatment time from symptom onset to reperfusion revealed that MGuard may increase the therapeutic window for physicians treating STEMI patients. This could be a very important factor when physicians assess clinical treatment options for their patients."
"It is very reassuring to see that the 12-month follow up data is consistent with the acute results presented at TCT last year, especially the data that shows the mortality benefit trend of using this unique technology," said Dariusz Dudek, physician-in-chief, 2nd Department of Clinical Cardiology and Cardiovascular Interventions, University Hospital in Krakow. "These positive results should give clinicians the confidence to use MGuard technology as a first line of defense against distal embolization for their STEMI patients."
The MASTER trial enrolled a total of 433 patients with STEMI presenting within 12 hours of symptom onset undergoing percutaneous coronary intervention (PCI) were randomized at 50 sites in nine countries to the MGuard EPS (n = 217) or commercially available bare metal or drug-eluting stents (n = 216).
MGuard EPS is CE mark-approved. It is not approved for sale in the United States at this time.
For more information: www.inspire-md.com