VESTAsync DES Trials Report Positive Results
September 19, 2008 – Last month, MIV announced continued positive results for VESTAsync, a polymer-free drug-eluting stent, at a twelve-month clinical follow-up for fifteen patients in its first-in-man VESTASYNC I Trial, reporting that all patients remain free of any major adverse cardiac events or MACE.
MIV also announced that it now has accumulated nine-month intravascular ultrasound (IVUS) and Quantitative Coronary Angiography (QCA) for these same patients. This data showed no statistical difference from the safety and efficacy data reported at four months.
Patients in the VESTASYNC I trial will be followed for two years and the company expects to continue to provide updates throughout the duration of the follow up period. Most importantly, says MIV, patients in the VESTASYNC I study have not been taking anti-platelet medication (Plavix) for almost one year now and remain event free.
MIV continues to enroll patients in the VESTASYNC II trial, a 120-patient randomized controlled study designed to demonstrate the safety and efficacy of the VESTAsync stent in a larger group of patients. It is anticipated that the VESTASYNC II results will form the basis of a regulatory filing for marketing approval in Europe. Building on the positive outcomes of the VESTASYNC I study, VESTASYNC II patients will be given anti-platelet medication (Plavix) for only three months, a marked reduction to the current anti-platelet standard, which is a minimum duration of one year and in many cases life-long therapy.
“We are pleased with the continued progress of our international trials and are confident MIV will reach approval for VESTAsync,” said Dr. Mark Landy, chief executive officer of MIV Therapeutics. “MIV remains focused on our objective to provide a safer drug-eluting stent requiring short-term anti-platelet therapy to cardiovascular patients in need.”
For more information: www.mivtherapeutics.com
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