“From our experience over the last two years, the MGuard Prime EPS has improved patient outcome and led to brilliant results, thanks to its unique protective mesh”
Embolic protection stent company, InspireMD, Inc., has seen a first patient enrolled in its Master II IDE clinical trial to evaluate the safety and effectiveness of the MGuard™ Prime Embolic Protection Stent (EPS) in patients suffering from ST Elevation Myocardial Infarction (STEMI).
Background
Unlike other coronary stents The MGuard™ EPS is integrated with a precisely engineered micro net mesh that prevents the unstable arterial plaque and thrombus (clots) that caused the heart attack blockage from breaking off.
InspireMD says its device offers superior performance relative to standard stents in STEMI patients with regard to ST segment resolution, yet requires no change in current physician practice – an important factor in promoting acceptance and general use in time-critical emergency settings.
The study
The FDA trial, known as MASTER II (MGuard™ for Acute ST Elevation Reperfusion), is the second in a series of randomized clinical studies intended to validate the safety and effectiveness of the MGuard™ EPS platform and achieve registration with appropriate regulatory authorities worldwide.
The multi-center, randomized trial is expected to include up to 70 sites in the U.S. and Europe and as many as 1,114 patients. The results are intended to support the Company’s Investigational Device Exemption (IDE) application with the U.S. FDA to market the MGuard™ Prime MicroNet™ covered coronary stent system in the U.S.
The trial has two co-primary endpoints: superiority in complete ST resolution and non-inferiority in death and target vessel myocardial infarction. In addition, a 356 patient sub-study will be conducted to assess the effect of the MGuard Prime™ EPS on infarct size, as measured by Magnetic Resonance Imaging (MRI).
Company comments
“Enrolling our first patient in MASTER II is a very important milestone for the company. We are committed to advancing patient care through robust clinical research,” said Alan Milinazzo, InspireMD’s CEO and President. “MASTER II provides another important opportunity for us to demonstrate the safety of MGuard EPS and to validate its effectiveness compared to current standard of care treatment for STEMI patients.”
Physician comments
The first procedure was performed at ZNA Middelheim by Stefan Verheye, M.D. “Distal embolization and no-reflow are severe concerns when treating our STEMI patients. From our experience over the last two years, the MGuard Prime EPS has improved patient outcome and led to brilliant results, thanks to its unique protective mesh,” said Dr. Verheye. “I am excited about participating in the MASTER II Trial and enthusiastic about its potential impact on patient care worldwide.”
Regulatory status
MGuard™ EPS is CE Mark approved. It is not approved for sale in the U.S. by the FDA at this time.
Source: InspireMD, Inc., PR Newswire
