FDA Approves COBRA-REDUCE Trial for CeloNova's Cobra PzF Stent System

September 22, 2015—CeloNova BioSciences, Inc. announced that it has received conditional approval from the US Food and Drug Administration for the COBRA-REDUCE trial to study the Cobra PzF coronary stent system in patients at high risk of bleeding. The trial will be conducted under an investigational device exemption (IDE) from the US Food and Drug Administration (FDA).

COBRA-REDUCE is a multicenter, prospective, randomized trial that will be led by Principal Investigator Prof. Adnan Kastrati, MD, who is Professor of Medicine at ISAR Research Center in Munich, Germany. 

According to the company, the trial will evaluate if the Cobra PzF coronary stent, which features the company’s Polyzene-F nanocoating and a thin-strut design, can help reduce bleeding as compared to drug-eluting stents, by shortening the duration of dual-antiplatelet therapy to 14 days in patients treated with oral anticoagulation and undergoing percutaneous coronary intervention. 

CeloNova noted that this is a second major interventional cardiology trial for CeloNova in the United States. In February, the company announced accelerated enrollment completion of its PzF SHIELD IDE trial, which will support regulatory submission for FDA approval of the Cobra PzF stent.

The Cobra PzF coronary stent system is designed to improve healing and re-endothelialization by reducing thromobogenicity and restenosis in comparison to bare-metal stents, without the need for long-term blood thinning agents associated with drug-eluting stents. The device received CE Mark approval in 2012 and was launched in Europe and the Middle East in 2013. It is an investigational device in the United States, advised CeloNova.