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
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