Our readers will probably be familiar with InspireMD, Inc., the company having developed the embolic protection stent, effectively a stent with an inbuilt net that prevents break-off of vessel plaque. At TCT2013 this week the company has announced new 12-month study data which, it says, demonstrates that the MGuard outperformed bare metal and drug eluting stents in all-cause mortality in ST segment elevation myocardial infarction (STEMI) patients.
The MGuard stent utilizes 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 advanced technology allows the MGuard to specifically address the unmet need for STEMI patients, and save the life of those who suffer from heart attacks.
ST-segment resolution is historically known to be a strong predictor of mortality. The MASTER (MGuard for Acute ST Elevation Reperfusion) trial enrolled 433 patients with STEMI presenting within 12 hours of symptom onset undergoing percutaneous coronary intervention. Patients 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).
The study achieved its primary endpoint (p value = 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 compared to the control (1.0% vs. 3.3%, p=0.092) at 12 months. These findings are in line with the previously announced 6 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% vs. 2.8%, p=0.056).
“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,” stated Prof. Dariusz Dudek, Physician-in-Chief, 2nd Department of Clinical Cardiology and Cardiovascular Interventions at the 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 positive follow-up data presented at TCT suggests that our MGuard EPS offers STEMI patients a higher likelihood of survival at 12 months than standard bare metal and drug eluting stents,” stated Alan Milinazzo, President and Chief Executive Officer of InspireMD. “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. 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.”
Source: InspireMD, Inc.