InspireMD (OTC:NSPR) presented new 6-month follow up data for its MASTER trial showing lower mortality rates in patients treated with its MGuard stent. The company’s findings were presented today at the STEMI symposium of the annual EuroPCR meeting in Paris, France.
The trial measured all-cause mortality for patients treated with the company’s MGuard stents compared to a control group treated with bare metal stents or drug-eluting stents.
Of the 433 patients in the study, those treated with MGuard had better survival rates at 6 months. The MGuard device is designed to prevent strokes after carotid artery stenting procedures, and relies on a proprietary mesh called MicroNet to prevent clots.
The Tel-Aviv, Israel-based medical device company also found that patients treated with either MGuard or MGuard Prime had better rates of epicardial coronary flow and complete ST-segment resolution (tissue damage measurement) at 6 months. InspireMD will continue to monitor patients for a 1 year follow up, which it will present at the Transcatheter Cardiovascular Therapeutics conference in the fall of 2013.
"The initial Master trial results published in the Journal of the American College of Cardiology in October 2012 demonstrated the acute benefits of the embolic protection stent, as MGuard EPS outperformed drug-eluting and bare metal stents in complete ST-segment resolution," Sigmund Silber, director of the Heart Center at the Isar Academic Teaching Site of the University of Munich, said in prepared remarks. "The six-month Master results highlight the enduring benefits of the MGuard EPS, with a consistent trend in lower mortality."
MGuard won approval in Europe in March, and InspireMD has its eyes on U.S. markets. The company recently added some $23 million to its coffers in a public stock offering to seek U.S. approval for the MGuard stent and the FDA just gave InspireMD FDA conditional permission to proceed with a new, 1,114 patient clinical trial for the device.