MIV Therapeutics, Inc., a leading developer of next-generation biocompatible polymer-free drug-eluting stents and advanced drug delivery systems, has announced that a comparative animal study of two of its novel polymer-free drug-eluting stent coating technologies has concluded with positive results.
This study compared stents coated with MIVT's polymer-free drug-eluting technologies to the J&J Cypher stent, one of the world's best selling drugeluting stent. The Study successfully demonstrated that both of MIVT's proprietary, polymer-free, Sirolimus eluting coatings are at least as good as Johnson & Johnson's Cypher Stent. The study also demonstrated MIVT's coatings' potential and efficacy when compared to Cypher.
The independently conducted four-week porcine study, performed by the Department of Cardiology, Thoraxcenter, Erasmus University Medical Center in the Netherlands, indicated that three variations of MIV's polymer-free Drug-Eluting coatings were at least as effective as and in some cases, better than Johnson & Johnson's Cypher, one of the world's leading drug-eluting cardiovascular stents.
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 stent.
The study concluded that MIV's HAp coating, with or without drugs, demonstrated highly promising performance. Based on these results the company will begin preparations for human implantation.
"The results of this study indicate that our drug-eluting polymer-free technologies are at least on par with the best in the world. We believe we have very strong candidates for a superior product as we move into the next phase of our regulatory program," said Dr. Mark Landy, president of MIV Therapeutics.
The study was conducted in a standard model of porcine coronary arteries and utilized angiography and histology to evaluate tissue response to stents coated with MIVT's proprietary polymer-free coatings in comparison to identical bare metal stents and also stents coated with MIVT's proprietary Sirolimus eluting technology to J&J's Cypher (Sirolimus) 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, noninflammatory 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. Recent information presented at leading cardiology conferences estimated that blood clots have been identified in at least 20,000 cases of implanted drug-eluting stents to-date, resulting in approximately 8,000 premature deaths.
MIVT recently announced that it intends 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 polymerfree drug-eluting stents that could provide patients with superior outcomes.