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 The leading web portal for pharmacy resources, news, education and careers March 24, 2017
Pharmacy Choice - Pharmaceutical News - CeloNova Biosciences Receives FDA Approval of COBRA PzF? Stent System - March 24, 2017

Pharmacy News Article

 3/16/17 - CeloNova Biosciences Receives FDA Approval of COBRA PzF? Stent System

By a News Reporter-Staff News Editor at Politics & Government Week CeloNova BioSciences, Inc. (CeloNova) announced that it has received U.S. Food and Drug Administration (FDA) approval of its first-in-class COBRA PzF? NanoCoated Coronary Stent System. Regulatory approval of the novel stent system was based on findings from the pivotal PzF SHIELD clinical trial, which successfully met its primary safety and effectiveness endpoints at 9-month follow-up, demonstrating no stent thrombosis and low clinically driven target lesion revascularization (TLR) of 4.6 percent.i Coated with a proprietary nano-thin polymer that is designed to be highly biocompatible, the COBRA PzF stent requires a minimum 30-day dual antiplatelet therapy (DAPT) regimen following intervention.ii The COBRA PzF stent is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries with reference vessel diameter (RVD) of 2.5-4.0mm and lesion length of =24mm.

"There continues to be an unmet clinical need for patients who may not be candidates for drug-eluting stents or longer term dual antiplatelet therapy," said Donald Cutlip, M.D., principal investigator and professor of medicine at Beth Israel Deaconess Medical Center and Harvard Medical School in Boston. "Given the observed low rates of stent thrombosis and target lesion revascularization that need to be confirmed in future studies, the COBRA PzF stent system may hold potential unique benefits for these patients."

Keywords for this news article include: Chemicals, CeloNova BioSciences Inc., Government Agencies Offices and Entities.

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