October 21, 2008 - MIV Therapeutics Inc., a developer of coatings and drug-delivery systems for cardiovascular stents and implantable devices, said its technology was highlighted in the Oct. 21 issue of the Journal of the American College of Cardiology Intervention (JACC Intervention).
The peer-reviewed article, “Preliminary Results of the Hydroxyapatite Non-Polymer-Based Sirolimus-Eluting Stent for the Treatment of Single De Novo Coronary Lesions - A First-In-Human Analysis of a Third Generation Drug-Eluting Stent (DES) System,” published preliminary results from the VESTASYNC I trial.
The article, authored by J. Ribamar Costa, Jr., M.D. et al, describes the positive results from the four-month follow-up of a multi-center, 15-patient, first-In-man study led by principal investigator Alexandre Abizaid, M.D., Ph.D., chief of coronary intervention of Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil. The VESTAsync drug-eluting stent was successfully implanted in all cases, and there were no procedure and in-hospital complications. Life-long aspirin and five-month clopidogrel therapy were prescribed for all patients. At four months, in-stent late lumen loss was 0.30 0.25 mm and percent of stent obstruction was 2.8 2.2 percent. The VESTAsync drug-eluting stent late loss of 0.30 mm situates this new device among the highest-efficacy DES, with the advantage of a polymer-free system using less drug than first-generation equivalents. After up to six months of clinical follow-up, no major adverse cardiac event was registered.
At the Transcatheter Cardiovascular Therapeutics (TCT) conference in October 2007, Dr. Abizaid presented four-month follow-up efficacy data on 13 patients in the 15-patient study. The company has since reported excellent data at 12-months clinical follow up on all 15 patients.
MIV Therapeutics is currently in a pivotal trial for VESTAsync, the company’s polymer-free drug-eluting stent. The VESTASYNC II trial is a 120 randomized controlled study designed to demonstrate the safety and efficacy of the VESTAsync where patients are given anti-platelet medication (Plavix) for only three months. The current anti-platelet standard is a minimum duration of one year and in many cases is life-long therapy.
For more information: www.mivtherapeutics.com, http://interventions.onlinejacc.org