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MGuard(TM) Coronary Stent System Approved in Israel
Date:12/8/2008

n 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.

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