TEL AVIV, Israel, May 6 /PRNewswire/ -- InspireMD, developers of MGuard(TM), announced today that the first patient has been enrolled in the iMOS registry. MGuard(TM) was successfully implanted at the General University Hospital in Prague; the procedure was performed by Dr. Jan Horak.
InspireMD plans to enroll 1000 'real world' Mguard(TM) patients. The registry, which is a post market study, will be conducted in Europe, Asia and South America. Data from the registry, an unselected heterogeneous population, will be used to support data from other clinical studies.
The first patient in the iMOS registry was a 54 year old male treated for acute myocardial infarction (STEMI) caused by a thrombus occluding the LAD artery. MGuard(TM) was successfully delivered and the patient was released from the hospital after a few days with no complications. Dr. Horak stated: I feel MGuard(TM) offers enhanced safety during the procedure by preventing defragmentation of the thrombus. I look forward to seeing good clinical results for both the one-month and the six-month follow periods.
Mr. Eli Bar CTO and VP RD stated: The iMOS registry is very important for us in order to understand the clinical performance of MGuard(TM) and to be able to analyze special patient subgroups and modes of use of the MGuard(TM). Currently the MGuard(TM) is mostly used in AMI, SVG, and thrombus containing lesions. We hope that the iMOS registry will give us a wider perspective on its use.
Dr. Alexandre Abizaid, one of the principal investigators of the iMOS registry commented: We are having a very positive experience with the MGuard(TM). The iMOS is going to broaden our understanding of the MGuard(TM) performance in larger and less homogenous populations.
Currently, two clinical trials with Mguard(TM) are underway. The GUARD Trial (MGuard in SVG and Native Coronaries Trial) is being conducted in Brazil, where the Principal Investigator is Dr. Alexandre Abizaid and the MAGICAL Trial (MGuard in Acute Myocardial Infarction Study) in Poland with Dr. Dariusz Dudek as Principal Investigator. The MAGICAL trial will include 60 STEMI patients, and its primary endpoints are complete ST segment resolution and restoration of flow through the occluded artery. New results from the MAGICAL and the GUARD studies are expected during the EUROPCR '09 in May in Barcelona.
About MGuard(TM) Coronary
MGuard(TM) presents a novel combination of a coronary stent merged with an embolic protection. The embolic protection is comprised of an ultra-thin polymer mesh sleeve that wraps the stent. The protective sleeve is composed of a micron-level-fiber which is knit in order to ensure flexibility while retaining the strength characteristics of the fiber material. The sleeve is designed to expand seamlessly when the stent is deployed, without effecting the structural integrity of the stent. The MGuard(TM) coronary stent provides permanent embolic protection, without complicating deliverability. Reduced injury to the vessel as a result of diffused stent pressure is a benefit of the sleeve which may lead to lower risk of restenosis. MGuard(TM) is CE Mark approved.
The MGuard(TM) 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 system technology, MGuard(TM). 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: restenosis, embolic showers, and late thrombosis.
In addition to providing embolic protection and minimizing arterial injury, this promising technology can be an effective and uniform drug delivery mechanism with the help of the novel micron-level net 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 further information visit http://www.inspire-md.com
Contact: Jonina Ohayon Marketing Director Tel +972-52-5791120 jonina@inspire-md.com
Contact: Jonina Ohayon, Marketing Director, Tel +972-52-5791120, jonina@inspire-md.com
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