TEL AVIV, Israel, December 8 InspireMD, Ltd. announcedthat the MGuard(TM) coronary stent system has been approved for use in Israelby the Israeli Ministry of Health.
The MGuard(TM) stent system presents a novel combination of a coronarystent merged with an embolic protection device. Lifelong embolic protectionis achieved by an expandable, flexible fishnet style, micron level knitsleeve that wraps the stent. In addition, MGuard(TM) blocks embolic showersand plaque detachment from the arterial wall, blocking debris at the sourceduring and post procedure. The net is designed to diffuse stent pressure onthe vessel wall, thereby reducing injury and lowering the likelihood ofrestenosis. Since MGuard(TM) received CE Mark approval in November 2007 theproduct has been met with much enthusiasm and celebrated by leadinginterventional 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 havebeen eager to have this life saving stent system available at their hospitalsand already in the few days since the local approval, lives of Israelis havebeen saved with MGuard(TM)". MGuard's relatively early regulatory approval inIsrael may have been partly due to numerous recommendations by local opinionleaders to the Ministry of Health.
InspireMD will celebrate the launch of MGuard(TM) in Israel at theupcoming ICI '08 Meeting in Tel-Aviv, December 8th-9th where MGuard(TM) willbe demonstrated at booth #18. In addition, InspireMD will be hosting aninspiring cocktail reception symposium on December 8th at the ICI Meeting,MGuard(TM): A Unique Solution for Managing Embolic Complications in Acute MIand SVG. Martin Leon MD and Chaim Lotan MD will chair the meeting whereadditional speakers include key world renowned interventional cardiologistsMartin Rothman MD and Dariusz Dudek MD.
In the past year, MGuard(TM) has been successfully implanted in complexlesions in live cases at major interventional cardiology congresses such asJIM '08, PCR '08 and TCT '08. The procedures were performed by top opinionleaders including Prof. Antonio Colombo, Prof. Eberhard Grube and Dr. DariuszDudek. Two clinical trials with MGuard(TM) are currently underway. TheMAGICAL Trial (MGuard in SVG and Native Coronaries Trial) is being conductedin Brazil and the GUARD Trial (MGuard in Acute Myocardial Infarction Study)in Poland. The main objective of the MAGICAL trial is to investigate thesafety and efficacy of the MGuard stent in human subjects who are candidatesfor 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 minimalresidual stenosis within the stented segment. Six-month angiographicfollow-up has started and enrollment is ongoing.
The GUARD Study is a prospective, multi center study, designed to confirmthe feasibility, efficacy and safety of MGuard(TM) in acute MI patients. TheGUARD study has reached 18 patients (out of the 60 planned) with acute STEMIwho received the MGuard stent with no additional distal embolization oraspiration device. The primary endpoint is ST resolution and TIMI flow, andfollow up is up to six months. The study's primary endpoints are completeresolution of ST-segment elevation and restoration of flow through theoccluded artery. Intermediate results will be presented this week at the ICI'08 Meeting in Tel-Aviv. iMOS (international MGuard Observational study) willbe launched soon. The iMOS study will enroll 1000 patients in an openregistry.
InspireMD, Ltd. is an innovative medical device company focusing on thedevelopment and commercialization of its proprietary stent system technology,MGuard(TM). The company intends to apply its technology to develop productsused in interventional cardiology and other vascular procedures. InspireMD'smission is to utilize its proprietary technology to make its products theindustry standard for stents and to provide a superior solution to the keyclinical issues of current stenting procedures: restenosis, embolic showers,and late thrombosis.
In addition to providing embolic protection and minimizing arterialinjury, this promising technology is aimed at providing an effective anduniform drug delivery mechanism for next generation drug eluting stents.InspireMD intends to pursue applications of this technology both for baremetal and drug eluting stents in coronary, carotid and peripheral arteryprocedures. For further information visit http://www.inspire-md.comContact: Jonina Ohayon Marketing Director Tel +972-52-5791120 firstname.lastname@example.org
SOURCE InspireMD, Ltd.