Early Data Presented From First-in-Man Study of CeloNova's Cobra PzF Stent

September 16, 2014—CeloNova BioSciences, Inc. announced that results from its first-in-man clinical trial showed that the company’s Cobra PzF coronary stent system, which features a cobalt chromium super alloy and a nanothin coating of the company’s Polyzene-F polymer, is a safe and effective routine interventional treatment for real-world and complex patients with heart disease. The data were presented at the Transcatheter Cardiovascular Therapeutics 2014 scientific symposium in Washington, DC.

In March, CeloNova announced US Food and Drug Administration approval to begin an investigational device exemption trial of the Cobra PzF coronary stent system in the United States. Donald E. Cutlip, MD, Professor of Medicine at Harvard Medical School in Boston, Massachusetts, serves as Principal Investigator of the trial.

According to CeloNova, the prospective, single-center study included 100 patients, many of whom presented with multivessel disease, complex lesions, and comorbidities such as diabetes, hypertension, dyslipidemia, atrial fibrillation, history of percutaneous coronary intervention, previous myocardial infarction, and more. 

The investigators reported 100% angiographic success. After treatment, patients were placed on a 30-day anticoagulant regimen of aspirin (1–2 mg/kg/d) and clopidogrel (1–2 mg/kg/d). At 6-month follow-up, the investigators found a 4% rate of major adverse coronary events that included three target lesion revascularizations, one cardiac death due to terminal cardiac insufficiency, no stent thrombosis, and no myocardial infarctions. 

In the company’s press release, Luc Maillard, MD, Lead Investigator of this first-in-man study, commented, “The COBRA PzF coronary stent system’s 66-month clinical performance is impressive given the wide variety of challenging patients in this study. Even more remarkable, and exciting, are the low TLR and MACE rates, as well as the absence of major bleeding complications related to the 30-day limit on dual-antiplatelet therapy. These data add to recent animal studies showing that Polyzene-F nanocoating technology is associated with rapid healing and re-endothelialization and may reduce stent thrombosis and restenosis without the use of long-term blood thinning medication."