MAGICAL Trial Tests MGuard Embolic Protection Stent in MI
May 21, 2009 - InspireMD Ltd. said today it completed enrollment for the MAGICAL Trial (MGuard in Acute Myocardial), which is 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, and the principal investigator is 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 (MBG) and MACE (major adverse cardiac events) at discharge, 30 days and six months.
"I am very pleased and excited we reached this milestone,” Dr. Dudek said. “From the data collected so far, primary PCI for STEMI patients using MGuard seems highly safe and effective".
To date, TIMI flow 3 is 91 percent, MBG 3 is 74 percent and complete ST resolution is 63 percent. MACE at discharge is zero and 30 days MACE to date is zero as well.
The company said the study shows the MGuard’s role in the treatment of acute MI patients by providing a comprehensive solution to the distal embolization threat. InspireMD said the MAGICAL Trial results are confirming that the MGuard performs well and delivers extra safety for the patients.
MGuard 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 that 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 affecting the structural integrity of the stent. The MGuard coronary stent provides permanent embolic protection, without complicating deliverability, the company said. 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 is CE mark approved.
For more information: www.inspire-md.com
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