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TEL AVIV, Israel, December 8TEL AVIV, Israel, December 8 /PRNewswire/ -- InspireMD, Ltd. announced that the MGuard(TM) coronary stent system has been approved for use in Israel by the Israeli Ministry of Health.
The MGuard(TM) stent system presents a novel combination of a coronary stent merged with an embolic protection device. Lifelong embolic protection is achieved by an expandable, flexible fishnet style, micron level knit sleeve that wraps the stent. In addition, MGuard(TM) blocks embolic showers and plaque detachment from the arterial wall, blocking debris at the source during and post procedure. The net is designed to diffuse stent pressure on the vessel wall, thereby reducing injury and lowering the likelihood of restenosis. Since MGuard(TM) received CE Mark approval in November 2007 the product has been met with much enthusiasm and celebrated by leading interventional cardiologists worldwide. "We are very excited about MGuard(TM) being approved for use in Israel so soon" stated Dr. Asher Holzer, InspireMD's President. "Our leading Israeli Interventional Cardiologists have been eager to have this life saving stent system available at their hospitals and already in the few days since the local approval, lives of Israelis have been saved with MGuard(TM)". MGuard's relatively early regulatory approval in Israel may have been partly due to numerous recommendations by local opinion leaders to the Ministry of Health.
InspireMD will celebrate the launch of MGuard(TM) in Israel at the upcoming ICI '08 Meeting in Tel-Aviv, December 8th-9th where MGuard(TM) will be demonstrated at booth #18. In addition, InspireMD will be hosting an inspiring cocktail reception symposium on December 8th at the ICI Meeting, MGuard(TM): A Unique Solution for Managing Embolic Complications in Acute MI and SVG. Martin Leon MD and Chaim Lotan MD will chair the meeting where additional speakers include key world renowned interventional cardiologists Martin Rothman MD and Dariusz Dudek MD.
In the past year, MGuard(TM) has been successfully implanted in complex lesions in live cases at major interventional cardiology congresses such as JIM '08, PCR '08 and TCT '08. The procedures were performed by top opinion leaders including Prof. Antonio Colombo, Prof. Eberhard Grube and Dr. Dariusz Dudek. Two clinical trials with MGuard(TM) are currently underway. The MAGICAL Trial (MGuard in SVG and Native Coronaries Trial) is being conducted in Brazil and the GUARD Trial (MGuard in Acute Myocardial Infarction Study) in Poland. The main objective of the MAGICAL trial is to investigate the safety and efficacy of the MGuard stent in human subjects who are candidates for a PCI due to a narrowing of a native coronary artery or a bypass graft. Since November 2007, 24 patients out of 60 planned have been enrolled. Preliminary angiographic data has demonstrated high acute gain and minimal residual stenosis within the stented segment. Six-month angiographic follow-up has started and enrollment is ongoing.
The GUARD Study is a prospective, multi center study, designed to confirm the feasibility, efficacy and safety of MGuard(TM) in acute MI patients. The GUARD study has reached 18 patients (out of the 60 planned) with acute STEMI who received the MGuard stent with no additional distal embolization or aspiration device. The primary endpoint is ST resolution and TIMI flow, and follow up is up to six months. The study's primary endpoints are complete resolution of ST-segment elevation and restoration of flow through the occluded artery. Intermediate results will be presented this week at the ICI '08 Meeting in Tel-Aviv. iMOS (international MGuard Observational study) will be launched soon. The iMOS study will enroll 1000 patients in an open registry.
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 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 further information visit http://www.inspire-md.com
Contact: Jonina Ohayon Marketing Director Tel +972-52-5791120 jonina@inspire-md.com
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