Healthcare Industry News: embolic protection
News Release - October 22, 2007
InspireMD's MGuard(TM) Coronary Stent Receives CE Mark
The MGuard(TM) Coronary Stent is Approved for Marketing in Countries in Europe, Latin America, Asia and AfricaTEL AVIV, Israel--(HSMN NewsFeed)--InspireMD, Ltd. today announced that its MGuardTM Coronary Stent has received CE Mark approval to treat patients with coronary artery diseases. The CE Mark allows MGuard™ Coronary to gain access to markets in the European Union (“EU”). In addition, the approval clears the way to market the MGuardTM Coronary in other countries that recognize the CE Mark in Europe, Latin America, Asia and Africa.
“This is a major achievement for InspireMD,” said Ofir Paz, InspireMD Chief Executive Officer and Chairman of the Board. “MGuard™ Coronary stent receives the ‘green light’ to compete in a market worth more than $3 billion annually. Designed to enhance the safety of stenting procedures, we are confident that MGuard™ Coronary provides advantages over other available coronary stents and is well positioned to capture a significant share of this large and growing market.”
MGuard™ Coronary Stent is designed to provide an embolic shower protection during and post stenting procedure. It is indicated to treat patients with coronary artery disease. In ongoing clinical trials conducted in Germany to date, the MGuard™ Coronary has achieved a procedural success rate of 100% with no report of any major adverse cardiac events.
“Our product’s innovative concept and development efforts achieved an important regulatory milestone that clears the way for InspireMD to commercialize and further develop and expand its operations in interventional cardiology,” said Dr. Asher Holzer, InspireMD President. “Cardiologists around the world are excited about the product, its concept and its applicability in a variety of coronary stenting procedures. We have already received pre-launch orders valued at over $1.5 million, and the CE Mark paves the way to generate significant sales volume and wide market adoption of our proprietary stent platform technology.”
About MGuard™ Coronary
The MGuardTM Coronary stent presents a novel combination of a coronary 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 may reduce injury and lower the likelihood of restenosis.
The MGuardTM Coronary’s innovative concept has enjoyed an enthusiastic welcome from leading interventional cardiologists around the world.
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 late thrombosis.
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.
For more information about the company and its products please visit its website at: www.inspire-md.com
Source: InspireMD
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