InspireMD Announces Enrollment of First Patients in the MGuard(TM) Acute Myocardial Infarction Clinical Trial Data Will be Used to Confirm Initial Positive Results
"It is very exciting for me to see this study take off and confirm ourexpectations," said Dr. Dariusz Dudek, the GUARD Study Chief Investigator,from Jagiellonian University in Krakow, "The MGuard(TM) represents a veryinnovative approach to the management of thrombus and embolization, whichadversely affect the prognosis and survival rate of a large proportion ofAcute MI patients. From the cases of acute MI where MGuard(TM) was implantedso far in various countries, we learned that the results were very successfuland that the product has a strong efficacy and safety profile with anexceptional deliverability. I look forward to confirm these initial findingsthrough this study."
"The successful clinical development of MGuard(TM) will benefit Acute MIpatients throughout the world," said Eli Bar, CTO and VP R&D of InspireMD,"MGuard(TM) is designed to provide a comprehensive solution to theembolization threat, during and post procedure. We are confident that theGUARD Study will confirm what we have experienced so far in cath labs aroundthe world that the product performs well and delivers extra safety to acuteMI patients."
The GUARD Study is a prospective, multi center study, designed to confirmthe feasibility, efficacy and safety of MGuard(TM) in acute MI patients. TheGUARDS study will include 60 patients, and its primary endpoints are completeresolution of ST-segment elevation and restoration of flow through theoccluded artery.
About MGuard(TM) Coronary
The MGuard(TM) 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(TM) 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 of restenosis.
The MGuard(TM) 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 platformtechnology, MGuard(TM). The company intends to apply its technology todevelop products used in interventional cardiology and other vascularprocedures. InspireMD's mission is to utilize its proprietary technology tomake its products the industry standard for stents and to provide a superiorsolution to the key clinical 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 baremeta
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