Two novel polymer-free drug-eluting stent coating technologies tested in a comparative animal study has concluded with positive results, according to a release from Atlanta-based MIV Therapeutics.
A developer of next-generation biocompatible polymer-free DES and advanced drug delivery systems, MIVT says the study compared stents coated with its polymer-free drug-eluting technologies to the J&J Cypher stent and successfully demonstrated that both of MIVT's proprietary, polymer-free, Sirolimus eluting coatings are at least as good as Cypher. The study also demonstrated MIVT's coatings' potential and efficacy when compared to Cypher(TM).
Dr Willem J. van der Giessen, MD, PhD, Interventional Cardiologist and Dr. Heleen M.M van Beusekom, PhD, Experimental Cardiology, from the Thoraxcenter at the Erasmus University Medical Center were the study directors. The objectives of the study were to evaluate the safety of MIVT's Hydroxyapatite coating and to assess the efficacy of MIVT Sirolimus coated stents in a porcine coronary model.
The results from the first part of the study, conducted with no drug added to the coatings, showed that HAp coated stents and bare metal stents did best and performed equally well.
The results from the second part of the study, with drugs added to the coatings, showed that all of the MIVT drug-eluting technologies performed at least as well, and in some cases better than the industry's benchmark, the J&J Cypher(TM) stent.
MIV Therapeutics is developing a diverse suite of Polymer-Free HAp coating formulas to improve the biocompatibility of stents and other implantable medical devices. Hydroxyapatite (HAp) occurs naturally in human bones and teeth. It rapidly integrates into the human body and has been shown to have excellent stability and biocompatibility. HAp is non-toxic, non-thrombogenic, non-inflammatory and has been shown to promote angiogenesis. HAp coatings are also expected to reduce the increased risk of deadly blood clots currently associated with today's polymeric drug-eluting stents.
The company says it plans to begin the first human implants of a HAp Nano Film Coated stent early in 2007. Human implantation represents a significant milestone in MIVT's strategic plan to develop a new class of polymer-free drug-eluting stents that could provide patients with superior outcomes.