FDA Approves CeloNova's Cobra PzF Stent System
March 1, 2017—CeloNova BioSciences, Inc. announced US Food and Drug Administration approval of its Cobra PzF polyzene-F nanothin polymer-coated coronary stent system. The Cobra PzF stent received CE Mark approval in 2012 and launched in Europe and the Middle East in 2013.
CeloNova advised that the Cobra PzF stent is indicated for improving coronary luminal diameter in patients—including those with diabetes mellitus—with symptomatic ischemic heart disease caused by de novo lesions in native coronary arteries with a reference vessel diameter of 2.5 to 4 mm and a lesion length of ≤ 24 mm. The device requires a minimum 30-day dual antiplatelet therapy regimen after intervention.
Cobra PzF combines a cobalt chromium platform with the company's PzF nanothin polymer. The coating, which is designed to be highly biocompatible, was shown in preclinical testing to have thromboresistant, anti-inflammatory, and rapid healing effects.
According to the company, approval of the device was based on findings from the pivotal PzF SHIELD clinical trial. The company recently announced the publication of the global multicenter study's 9-month findings by Principal Investigator Donald E. Cutlip, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2017;10:160–167). PzF SHIELD met its primary safety and effectiveness endpoints at 9-month follow-up, demonstrating no stent thrombosis and a low clinically driven target lesion revascularization of 4.6%.
In CeloNova's announcement, Dr. Cutlip commented, “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. 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 potentially unique benefits for these patients.” Dr. Cutlip is Professor of Medicine at Beth Israel Deaconess Medical Center and Harvard Medical School in Boston, Massachusetts.
Renu Virmani, MD, President of the CV Path Institute in Gaithersburg, Maryland said, “The stent’s PzF nanocoating is truly cutting edge with good biocompatibility. We continue to observe its thromboresistant and rapid endothelialization properties, which give us confidence to believe that Cobra PzF is a good stent option for patients who are at a high risk for bleeding following coronary intervention.”
CeloNova advised that it is continuing to study the Cobra PzF stent in the COBRA-REDUCE trial, which began enrollment in February 2016. This randomized controlled trial will evaluate whether the Cobra PzF stent can help reduce bleeding as compared to drug-eluting stents by shortening the duration of dual antiplatelet therapy to 14 days in patients who are at high risk for bleeding and require treatment for coronary artery disease.