TEL AVIV, Israel, October 15 InspireMD, Ltd. announcedthat the MGuard(TM) coronary stent system was celebrated by hundreds ofItaly's leading cardiologists at the GISE 24th National Congress of theItalian Society of Invasive Cardiology in Bologna, Italy, September 23-26,2008. The GISE meeting is attended by over fifteen hundred of Italy's leadingcardiologists. During the first day of the meeting over seven hundredinterventional cardiologists lined up to visit the MGuard display at theexhibit of Kardia Srl, InspireMD's distributor of the MGuard coronary stentsystem in Italy. "We are delighted with the overwhelming interest in theMGuard stent system at the GISE conference, hundreds of interventionalcardiologists streamed to our display at the conference daily- it was hardbut yet inspiring to meet everybody's interest in the MGuard" claimed Dr.Asher Holzer, InspireMD's President.
The vast interest in the MGuard stent system at GISE was in part derivedfrom Dr. Yaron Almagor's exciting presentation of the MGuard and its latestoutstanding clinical results. Dr. Yaron Almagor is the Director of CardiacCatheterization and Interventional Cardiology Laboratories at Jesselson HeartCenter, Shaare Zedek Medical Center Jerusalem, Israel and has been anAssociate and Co-Director at the Columbus Heart Center in Milan, Italy. Tofurther add to the excitement at GISE, Prof. Federico Piccioni from theFederico II University Hospital of Naples Italy presented the results of hiswork with MGuard. When sharing his experience using the MGuard, Prof.Piccioni stated "We deployed the MGuard stents in 70 acute MI patients. Thissuperb stent system, which includes the unique protective net, prevents theescaping of emboli into the bloodstream during and post procedure andprevents damage to the arterial wall - all this may lessen the chance forMyocardial Infarction".
Two clinical trials with MGuard are now underway. The MAGICAL Trial(MGuard in SVG and Native Coronaries Trial) is being conducted in Brazil andthe GUARD Trial (MGuard in Acute Myocardial Infarction Study) in Poland. Themain objective of the MAGICAL trial is to investigate the safety and efficacyof the MGuard stent in human subjects who are candidates for a PCI due to anarrowing of a native coronary artery or a bypass graft. Since November 2007,21 patients have been enrolled. The device has so far demonstrated anexcellent performance in a highly complex lesion subset, with no angiographicand/or procedural complications and 0% clinical events at 30 days. Six-monthangiographic follow-up has started and enrolment is ongoing. The GUARD Studyis a prospective, multi center study, designed to confirm the feasibility,efficacy and safety of MGuard(TM) in acute MI patients. The GUARDS study willinclude 60 patients, and its primary endpoints are complete resolution ofST-segment elevation and restoration of flow through the occluded artery. Thefirst 8 patients have been implanted successfully with the MGuard CoronaryStent, in the Jagiellonian University Clinic, in Krakow, Poland.
About MGuard(TM) Coronary
The MGuard Coronary stent presents a novel combination of a coronarystent merged with an embolic protection device. The embolic protection deviceis comprised of an ultra-thin polymer mesh protective sleeve, wrapped aroundthe stent. The protective sleeve is composed of a micron-level-fiber knittedmesh, engineered in an optimal geometric configuration and designed forutmost flexibility while retaining strength characteristics of the fibermaterial. The sleeve is designed to expand seamlessly when the stent isdeployed, without affecting the structural integrity of the stent, and toprevent plaque detachment during and post procedure. The MGuard Coronarystent provides long acting embolic protection, without adding complexity indeliverability. The sleeve is designed to diffuse stent pressure on thevessel wall, thereby may reduce injury and lower the likelihood ofrestenosis. MGuard is CE Mark approved.
The MGuard Coronary's innovative concept has enjoyed an enthusiasticwelcome from leading interventional cardiologists around the world.
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 [email protected]
SOURCE InspireMD, Ltd.