Medical device firm CeloNova BioSciences has obtained conditional approval from the US Food and Drug Administration (FDA) to commence an investigational device exemption (IDE) trial of the Cobra PzF coronary stent system in patients at high risk of bleeding.
The study is a second major interventional cardiology trial for the firm, after the successful enrollment in the PzF Shield clinical trial earlier this year.
The Cobra-Reduce multicenter, prospective and randomized trial will be led by Germany’s ISAR Research Center’s medicine professor Dr Adnan Kastrati.
It will assess whether the Cobar 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 BioSciences chief technology officer Jane Ren said: "The FDA approval to begin this important trial in the U.S. is another major milestone towards providing compelling clinical evidence to satisfy an unmet market need."
The accelerated enrollment for CeloNova’s PzF Shield IDE trial was completed in February this year and the data will be used to support regulatory submission for FDA approval of the Cobra PzF stent.
The Cobra PzF coronary stent system is an investigational device in the US, while it obtained CE mark approval in 2012 and was introduced in Europe and the Middle East in 2013.
CeloNova develops and markets a family of interventional cardiology and interventional radiology products.