Dec 15 2014
CeloNova BioSciences, Inc., today announced results from a First-in-Man (FIM) clinical trial presented by Luc Maillard, MD PhD, at the prestigious French Cardiology Meeting, GRCI, held in Paris, France. In his presentation entitled, “First-in-man expérience avec le stent Cobra-PzF, utilisant un nano-coating,” Dr. Maillard concluded that the COBRA PzF™ coronary stent system with advanced nano-thin coating of Polyzene™-F polymer can be a safe and effective interventional treatment for real-world and complex patients with heart disease.
The prospective, single-center study included 100 patients, many of whom presented with multi-vessel disease, complex lesions, and co-morbidities such as diabetes, hypertension, dyslipidemia, atrial fibrillation, history of PCI, previous myocardial infarction, and more. At six-month follow-up, results showed zero-percent (0%) stent thrombosis, zero-percent (0%) myocardial infarctions, one cardiac death due to terminal cardiac insufficiency (1%), and three-percent (3%) Target Lesion Revascularization (TLR), leading to four-percent (4%) Major Adverse Coronary Event (MACE).
“The COBRA PzF coronary stent system’s six-month clinical performance is impressive given the wide variety of challenging patients in this study. Even more remarkable are the low TLR and MACE rates as well as the absence of major bleeding complications related to the 30-day limit on dual-antiplatelet therapy,” said Dr. Maillard. “These data add to recent animal studies showing that the COBRA PzF stent and its nanocoating technology is associated with rapid healing and re-endothelialization, and may reduce stent thrombosis and restenosis without the use of long-term blood thinning medication.”
“The COBRA PzF coronary stent is designed to satisfy the unmet market need for a device that offers the short dual-antiplatelet therapy regimen associated with bare-metal stents, but with the possibility of lower restenosis rates,” said Kathryn Conner, Senior Vice President, Strategic Marketing, CeloNova. “CeloNova will continue to support the growing body of compelling clinical evidence for this exciting stent platform.”
About the Company
CeloNova BioSciences, Inc., headquartered in San Antonio, Texas, is a global medical device company that develops, manufactures and markets a family of Interventional Cardiology and Endovascular products. Our products are developed and manufactured in Carlsbad, California, U.S.A. and Ulm, Germany. The Company's regional offices are located in Germany, France, United Kingdom, Netherlands and Austria. For additional information about CeloNova BioSciences, see the company website at celanova.com.
Source: http://www.celonova.com/