CeloNova BioSciences 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 USA, following the successful enrolment of the PzF SHIELD clinical trial earlier this year.
This multicentre, prospective, randomised trial will be referred to as the COBRA-REDUCE trial. Professor Adnan Kastrati, 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).
“The Food and Drug Administration (FDA) approval to begin this important trial in the USA is another major milestone towards providing compelling clinical evidence to satisfy an unmet market need,” said Jane Ren, chief technology officer at CeloNova. “The Cobra PzF coronary stent system is designed to improve healing and re-endothelialisation by reducing thrombogenicity and restenosis in comparison to bare metal stents, without the need for long-term blood thinning agents associated with drug eluting stents.”
In February, CeloNova announced accelerated enrolment completion of its PzF SHIELD IDE trial, which will support regulatory submission for FDA approval of the Cobra PzF stent.
“We are encouraged by the initial positive outcomes of the Cobra PzF coronary stent system in initial studies and commercial use outside of the USA. We look forward to working with the FDA to bring this breakthrough technology to clinicians and patients here in the USA,” said Martin Landon, president and chief executive officer at CeloNova.
The Cobra PzF coronary stent system is an investigational device in the USA, received CE mark approval in 2012 and launched in Europe and the Middle East in 2013.