The US Food and Drug Administration (FDA) has granted approval to medical device firm CeloNova BioSciences to begin an investigational device exemption (IDE) trial to examine the COBRA PzF coronary stent system in patients at high risk of bleeding.
In the US, this is the company’s second major interventional cardiology trial and follows successful enrolment of the PzF SHIELD clinical trial earlier this year.
ISAR Research Center Professor of Medicine Adnan Kastrati will be the principal investigator of this multi-centre, prospective, randomised trial (COBRA-REDUCE).
The COBRA-REDUCE trial will evaluate if the COBRA PzF coronary stent, with its new Polyzene-F nano-coating and advanced thin-strut design, can help reduce bleeding 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 PCI.
CeloNova chief technology officer Jane Ren said: "The FDA approval to begin this important trial in the US is another major milestone towards providing compelling clinical evidence to satisfy an unmet market need.
"The COBRA PzF coronary stent system is designed to improve healing and re-endothelialisation 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."
In February, the company completed enrolment in its PzF SHIELD IDE trial, which will support regulatory submission for FDA approval of the COBRA PzF stent.
CeloNova president Martin Landon said: "We are encouraged by the initial positive outcomes of the COBRA PzF coronary stent system in initial studies and commercial use outside of the US.
"We look forward to working with the FDA to bring this breakthrough technology to clinicians and patients here in the US."
The COBRA PzF coronary stent system, an investigational device, secured CE Mark approval in 2012 and was launched in Europe and the Middle East in 2013.