CeloNova BioSciences, Inc. (CeloNova) has announced the publication of primary endpoint results from its global, multicenter PzF SHIELD clinical trial evaluating the first-in-class COBRA PzF™ NanoCoated Coronary Stent. The 9-month findings were published in the January 23rd issue of the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.
In the study, the COBRA PzF stent met pre-specified performance goals for both the primary endpoint of target vessel failure and the secondary endpoint of angiographic late lumen loss at 9-months post-intervention. The trial was conducted under an investigational device exemption from the U.S. Food and Drug Administration (FDA). As the first nanocoated stent to ever be evaluated in clinical trials in the United States, the COBRA PzF stent combines a unique, highly deliverable cobalt chromium platform design with a biocompatible Polyzene™-F nano-thin polymer.
“We are pleased to have met our primary endpoint and are reassured by low rates of stent thrombosis and target lesion revascularization that need to be confirmed in future studies,” said Donald Cutlip, M.D., principal investigator and professor of medicine at Beth Israel Deaconess Medical Center and Harvard Medical School in Boston. “The results hold potential unique benefit for patients who may not be candidates for drug-eluting stents or longer term dual antiplatelet therapy, a continued unmet clinical need.”
A total of 296 patients from 35 centers in the United States and abroad with symptomatic ischemic heart disease received treatment with the COBRA PzF stent in the single-arm, non-randomized trial, many of whom had co-morbidities including diabetes (33.7 percent), prior percutaneous coronary intervention (30.4 percent) and atrial fibrillation (12.2 percent).
“Continued investments in our clinical study programs underscore CeloNova’s commitment to develop an innovative stent platform that transforms the way we approach safety in the treatment of coronary artery disease,” said Dennert Ware, Executive Chairman and acting CEO, CeloNova Biosciences. “With this pivotal PzF SHIELD study primary endpoint complete, we have submitted the data to the FDA for review.”
Currently, the company is further studying the COBRA PzF stent in the COBRA REDUCE trial. This randomized controlled trial will evaluate the safety and efficacy of the COBRA PzF stent to reduce the need for long-term dual antiplatelet therapy in patients to 14 days who are at high-risk for bleeding and require treatment for coronary artery disease.
About the COBRA PzF NanoCoated Coronary Stent
The COBRA PzF NanoCoated Coronary Stent, the first nanocoated stent to ever be evaluated in clinical trials in the United States, combines a unique highly deliverable cobalt chromium platform with a Polyzene-F nano-thin polymer. Polyzene-F nanocoating is a proprietary, ultra-thin polymer that is designed to be durable, elastic and biocompatible, acting as a barrier between metal, blood and circulating elements. The COBRA PzF NanoCoated Coronary Stent received CE Mark approval in 2012 and launched in Europe and the Middle East in 2013. It is currently an investigational device and not approved for sale in the United States.
About CeloNova BioSciences
CeloNova BioSciences, Inc., is a global medical device company that develops, manufactures and markets a family of products based upon its novel Polyzene-F nanocoating technology. The next-generation nanocoating is the result of years of rigorous scientific research and German-engineering, and has been extensively published in numerous academic articles to date. For additional information about CeloNova BioSciences, please visit the company website at http://celonova.com/.
