InspireMD Stent Shows Promising Trial Results

InspireMD Inc. received positive results from its MASTER Trial, which evaluated its MGuard embolic protection stent (EPS). According to the company, the device was demonstrably superior to standard bare metal and drug-eluting stents in in achieving complete ST resolution (the shape of the ST segment on an electrocardiography reading can indicate abnormal heart activity) and restoring normal blood flow in a major study of 432 randomized patients undergoing emergency coronary intervention for potentially fatal heart attacks.

The findings, as reported by study chairman Gregg W. Stone, M.D., showed that the MGuard EPS may potentially lower the incidence of adverse sequelae (any chronic condition resulting from an acute condition, which in this case, is a heart attack) and prolong the survival of heart attack victims.

The study reportedly met its primary endpoint (the proportion of patients with ST segment resolution of greater than or equal to 70 percent, measured at 60 to 90 minutes after the procedure), showing the MGuard EPS was significantly superior to the control arm of bare metal and drug-eluting stents in treating heart attack patients.

According to the study, more patients treated with the MGuard (58 percent) achieved better blood flow restoration to the heart muscle than in the control arm (45 percent). The MGuard also showed a 92 percent improvement in coronary artery blood flow compared to the 83 percent improvement in the control arm. The trial showed a trend toward lower mortality at 30 days and smaller infarct size as measured by post procedure cardiac magnetic resonance imaging (commonly known as MRI) in the MGuard arm versus the control group. There was, however, no significant difference between the groups’ secondary endpoint of myocardial blush grade, which is an angiographic measure of blood flow to the cardiac muscle.
“I was impressed with the performance of the MGuard EPS in the MASTER trial,” said Stone. “Compared to standard stents, the MGuard is the first stent in a randomized trial shown to restore complete ST-segment resolution in a higher proportion of patients, a key predictor of myocardial salvage and long-term survival in STEMI (ST segment elevation myocardial infarction) patients.”

Stone is director of the Cardiovascular Research and Education Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center in New York, N.Y.

The MGuard EPS is integrated with a micro net mesh that prevents the arterial plaque and thrombus (clots) that caused the heart attack blockage from breaking off. The device is CE Marked, but is not approved for sale in the United States.

Tel Aviv, Israel-based InspireMD is a medical device company focused on developing and commercializing MGuard. The company intends to pursue applications of its technology in coronary, carotid and peripheral artery procedures.