InspireMD, Inc., the leader in embolic protection stents, never seems to be far from the headlines. Last week the company was advertising the fact that this week’s EuroPCR meeting would see it presenting some data. And lo and behold here it is, announcing new 6-month results from the MASTER (MGuard for Acute ST Elevation Reperfusion) trial at its own symposium held at EuroPCR. Results seemingly demonstrate that the MGuard Embolic Protection Stent (EPS) outperformed bare metal and drug eluting stents in all-cause mortality in ST segment elevation myocardial infarction (STEMI) patients.
As if that wasn’t enough, another fourteen presentations and three abstracts highlighting the MGuard EPS technology were presented over the 4-day conference.
Background
You’ll recall that MGuard EPS is a stent with a proprietary micro-net mesh sleeve, so it looks a bit like a very small “duty free” bottle protector. In acute heart attack patients, the plaque or thrombus is unstable and often breaks up as the stent is implanted causing downstream blockages (some of which can be fatal) in a significant portion of heart attack patients.
MGuard EPS is designed to prevent unstable arterial plaque and thrombus from breaking away from the lesion, so backing that design theory up with some practical clinical data is an obvious and important next step. Read on then.
In the MASTER trial, a total of 433 patients with STEMI presenting within 12 hours of symptom onset undergoing percutaneous coronary intervention were randomized at 50 sites in 9 countries to the MGuard EPS (n = 217) or commercially available bare metal or drug-eluting stents (n = 216).
Results show that the trial achieved its primary endpoint (p value = 0.008), in complete ST-segment resolution at 60-90 min post-procedure (a strong predictor of mortality). Secondary endpoint clinical outcomes continue to show a lower mortality rate with MGuard EPS compared to control (0.5% vs. 2.8%, P=0.06) at 6 months. These findings corroborate the previously announced 30-day results showing that all-cause mortality with MGuard EPS was lower than bare metal and drug eluting stents used as a control (0% vs. 1.9%, P=0.06).
Physician comments
“The initial MASTER trial results published in the Journal of the American College of Cardiology[1] in October 2012demonstrated the acute benefits of the embolic protection stent, as MGuard EPS outperformed drug-eluting and bare metal stents in complete ST-segment resolution,” said Professor Dr. Sigmund Silber , Director of the Heart Center at the Isar Academic Teaching Site of the University of Munich. “The six-month MASTER results highlight the enduring benefits of the MGuard EPS, with a consistent trend in lower mortality.”
Company comments
“The body of positive clinical evidence supporting the use of the MGuardEPS continues to grow,” said Alan Milinazzo , President and Chief Executive Officer of InspireMD. “Both the 6-month data and the subgroup analysis presented this week at EuroPCR inParis, suggest that our technology offers improved embolic protection over the current generation of bare metal and drug eluting stents for the STEMI patient. Advancing embolic protection without requiring physicians to increase procedure time or dramatically change their technique is a major benefit of the MGuard EPS.”
Regulatory status
MGuard EPS is CE Mark approved. It is not approved for sale in the U.S. by the Food and Drug Administration (FDA) at this time.
Source: InspireMD, Inc., PR Newswire
