InspireMD Announces Positive 6-Month Efficacy And Safety Results Of The MGuard(TM) Coronary Stent

Main Category: Cardiovascular / Cardiology
Article Date: 06 May 2008 - 2:00 PDT

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InspireMD announced continued positive results from the MGuard™ Coronary Stent First-in-Man, multi-center ongoing trial in Germany. This study aims at establishing the safety and efficacy of MGuard™ Coronary Stent in high risk patients with complex lesions. The study primary end point demonstrated 0% major adverse cardiac events (MACE) after 30 days in 60 patients, with 100% procedural success rate. Following these results, the company released the 6-month data of the first 30 patients. These data demonstrated no stent thrombosis and low overall MACE rate of 6.6% (2 target lesion revascularization cases, n=30). The data also highlight the efficacy of MGuard in maintaining blood flow through the treated vessel after 6 months. The late loss, a measurement of the reduced vessel diameter, was 0.38 mm and the restenosis rate was 6.6%.

"We are encouraged by this consistent, positive data from the follow-up of the MGuard trial," said Prof. Eberhard Grube, Chief of the Department of Cardiology/Angiology at the Helios Heart Center in Siegburg, Germany, and principal investigator of the MGuard trial, "MGuard™ represents an innovative approach to address the key issue of interventional cardiology - reduction of adverse events. These results confirm the important role that the net in MGuard™ plays in controlling embolic shower and reducing injury to the vessel. MGuard™ may well be an important addition to the arsenal of interventional cardiologist in treating Acute MI, acute coronary syndromes, saphenous vein graft (SVG) and arteries with thrombus."

The MGuardTM Coronary Stent presents a novel combination of a coronary stent merged with an embolic protection device. MGuard™ received CE Mark to treat patients with coronary artery diseases.

"The results of the 6-month data are exciting news for patients with coronary artery disease. The data is comparable with existing drug eluting stents, particularly the late loss and restenosis rate," comments Ofir Paz, CEO, InspireMD.

"It is remarkable that the net in MGuard™ transform its efficacy to a level comparable to drug eluting stents that exist in the market today," Comments Dr. Asher Holzer, President, InspireMD, "MGuard™ provides the interventional cardiologist with a new platform to reduce adverse events and to maintain blood flow through treated vessels."

About MGuard™ Coronary

The MGuard™ Coronary Stent is a bare metal stent merged with an embolic protection device. The embolic protection device is comprised of an ultra-thin polymer mesh protective sleeve, wrapped around the stent. The protective sleeve is composed of a micron-level-fiber knitted mesh, engineered in an optimal geometric configuration and designed for utmost flexibility while retaining strength characteristics of the fiber material. The sleeve is designed to expand seamlessly when the stent is deployed, without affecting the structural integrity of the stent, and to prevent plaque detachment during and post procedure. The MGuardTM Coronary stent provides long acting embolic protection, without adding complexity in deliverability. The sleeve is designed to diffuse stent pressure on the vessel wall, thereby reduce injury and lower the likelihood of restenosis.

About InspireMD

InspireMD, Ltd. is an innovative medical device company focusing on the development and commercialization of its proprietary stent platform technology, MGuard™. The company intends to apply its technology to develop products used in interventional cardiology and other vascular procedures. InspireMD's mission is to utilize its proprietary technology to make its products the industry standard for stents and to provide a superior solution to the key clinical issues of current stenting procedures: restenosis, embolic showers and no-reflow.

In addition to providing embolic protection and minimizing arterial injury, this promising technology is aimed at providing an effective and uniform drug delivery mechanism for next generation drug eluting stents. InspireMD intends to pursue applications of this technology both for bare metal and drug eluting stents in coronary, carotid and peripheral artery procedures.

http://www.inspire-md.com