FDA OKs Second Randomized Trial for COBRA PzF Coronary Stent System

September 23, 2015 — CeloNova BioSciences Inc. announced that it has received conditional approval to start an investigational device exemption (IDE) trial to study the Cobra PzF coronary stent system in patients at high risk of bleeding. This is a second major interventional cardiology trial for CeloNova in the United States, following the successful enrollment of the PzF SHIELD clinical trial earlier this year.

This multicenter, prospective, randomized trial will be referred to as the COBRA-REDUCE trial. Prof. Adnan Kastrati, M.D., professor of medicine at ISAR Research Center, Munich, Germany, is the trial’s principal investigator.

The trial will evaluate if the Cobra PzF coronary stent, with its novel Polyzene-F nano-coating and advanced thin-strut design, can help reduce bleeding as compared to drug-eluting stents by shortening the duration of dual antiplatelet therapy (DAPT) to 14 days in patients treated with oral anticoagulation and undergoing percutaneous coronary intervention (PCI).

In February this year, CeloNova announced accelerated enrollment completion of its PzF SHIELD IDE trial, which will support regulatory submission for U.S. Food and Drug Administration (FDA) approval of the Cobra PzF stent.

The Cobra PzF coronary stent system received CE Mark approval in 2012 and launched in Europe and the Middle East in 2013.

For more information: www.celonova.com