The polymer-free VESTAsync drug-eluting stent (DES) from MIV Therapeutics has the potential for superior safety and equivalent efficacy when compared to currently available DES, according to a moderated poster of preliminary data at the 2008 American College of Cardiology (ACC) Scientific Session.
The presentation concluded that the VESTAsync polymer-free nanoscale microporous hydroxyapatite stent demonstrates excellent efficacy and safety, according to Jose Costa, MD, from the Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil.
Costa presented nine-month follow-up intravascular ultrasound (IVUS) data for 11 patients, who demonstrated a volumetric obstruction of 3.8 percent vs. 2.8 percent at four months.
The investigators found that the quantitative coronary angiography (QCA) of 12 patients at nine months was a late-lumen loss of 0.37 mm vs. 0.31 mm at four months.
The researchers concluded that there was no significant difference between the four and nine-month results and that the observed degradation was uniform across all patients with no outliers. They also reported no late-acquired incomplete stent apposition, stent thrombosis or major adverse coronary events.
Costa said that the “preliminary nine-month data of the MIVT pilot trial are very encouraging, and reaffirm our positive findings at four months. The data compare favorably with first-in-man data of DES available in the U.S. and abroad, but what is more remarkable is these results were obtained with 60 percent less drugs delivered from an ultra-thin 0.6 micron coating that is entirely polymer-free.”
“We are looking forward to conducting a larger trial in the coming months to further support our belief that the VESTAsync has the potential to deliver DES efficacy with bare-metal stent safety, and short-term anticoagulant therapy. We expect to begin this trial in the second quarter of this year and look forward to providing updates as we move ahead,” said Mark Landy, MD, president and CEO of the Atlanta-based MIV.