Interventional cardiology and radiology company CeloNova BioSciences said today it won FDA approval to launch an investigational device exemption trial of its Cobra PzF coronary stent system for treating patients with a high risk of bleeding.
The prospective, randomized Cobra-Reduce trial is being led by Dr. Adnan Kastrati and examine the use of the stent during percutaneous coronary interventions.
“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 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,” CTO Jane Ren said in a press release.
The Cobra PzF coronary stent has a novel Polyzene-F nano-coating and thin-strut design, which San Antonio, Texas-based CeloNova says can reduce bleeding compared to drug eluting stents and shortens the duration of dual antiplatelet therapy by up to 2 weeks.
“We are encouraged by the initial positive outcomes of the Cobra PzF coronary stent system in initial studies and commercial use outside of the U.S. We look forward to working with the FDA to bring this breakthrough technology to clinicians and patients here in the United States,” CEO Martin Landon said in prepared remarks.
The Cobra PzF stent received CE Mark approval in the European Union in 2012 and was commercialized in Europe and the Middle East in 2013, the company said.
Last week, CeloNova said it launched a prospective registry study of its novel Cobra PzF coronary stent for treating heart disease.
The e-Cobra study, a prospective registry in France, is slated to enroll 1,000 patients with a primary endpoint assessing the rate of major adverse cardiac events, such as cardiac death, myocardial infarction and lesion revascularization, at 12 months.