BARCELONA, Spain, May 20 /PRNewswire/ -- InspireMD, Ltd. announced today the completion of enrolment for the MAGICAL trial (MGuard(TM) in Acute Myocardial). The trial was designed to confirm the clinical feasibility, safety and performance of MGuard when used during Primary PCI in STEMI patients.
The MAGICAL trial is a multicenter, prospective, single arm, 60 patients study (Principal investigator: Dr. Dariusz Dudek, Jagiellonian University, Krakow, Poland). Primary end-points are incidence of complete ST segment resolution measured 60 minutes post procedure and incidence of TIMI 3 flow after PCI. Main secondary endpoints are myocardial blush grade and MACE (major adverse cardiac events) at discharge, 30 days and 6 months.
"I am very pleased and excited we reached this milestone" said Dr. Dariusz Dudek, the MAGICAL Study Chief Investigator, from Jagiellonian University in Krakow. "From the data collected so far, primary PCI for STEMI patients using MGuardTM seems highly safe and effective".
To date, TIMI flow 3 is 91%, MBG 3 (Myocardial Blush Grade) is 74%, Complete ST Resolution is 63%. MACE at discharge is 0% and 30 days MACE to date is 0% as well.
"This important milestone is getting us closer to confirm MGuard's important role in the treatment of acute MI patients, by providing a comprehensive solution to the distal embolization threat" said Eli Bar, CTO and VP R&D at InspireMD. "So far, the MAGICAL Trial results are confirming what we had experienced in cath-labs around the world; that the MGuardTM performs well and delivers extra safety for the patients".
A presentation of the updated results of the MAGICAL trial by Dr. Dariusz Dudek will be given at the InspireMD Cocktail Reception, May 21st at 18:30 at the Hilton Diagonal Mar, next to the EuroPCR conference CCIB Conference center. The Cocktail Reception and Debate: "What is the Best Strategy in Acute MI?" will be chaired by the world renowned opinion leader, Martin Leon MD.
About MGuard(TM) Coronary
MGuard(TM) presents a novel combination of a coronary stent merged with an embolic protection. The embolic protection is comprised of an ultra-thin polymer mesh sleeve that wraps the stent. The protective sleeve is composed of a micron-level-fiber which is knit in order to ensure flexibility while retaining the strength characteristics of the fiber material. The sleeve is designed to expand seamlessly when the stent is deployed, without effecting the structural integrity of the stent. The MGuard(TM) coronary stent provides permanent embolic protection, without complicating deliverability. Reduced injury to the vessel as a result of diffused stent pressure is a benefit of the sleeve which may lead to lower risk of restenosis. MGuard(TM) is CE Mark approved.
The MGuard(TM) Coronary's innovative concept has enjoyed an enthusiastic welcome from leading interventional cardiologists around the world.
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: restenosis, embolic showers, and late thrombosis.
In addition to providing embolic protection and minimizing arterial injury, this promising technology can be an effective and uniform drug delivery mechanism with the help of the novel micron-level net 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 firstname.lastname@example.org
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