Nanocoated coronary stent system receives FDA approval

CeloNova BioSciences Inc. announced its novel first-in-class nanocoated coronary stent system has received FDA approval following the results of the of the PzF SHIELD clinical trial.

The stent (Cobra PzF), which is coated with a biocompatible proprietary nanothin polymer, requires a minimum 30-day dual antiplatelet therapy regimen after intervention, according to a press release issued by the company.

“There continues to be an unmet clinical need for patients who may not be candidates for drug-eluting stents or longer term [DAPT],” Donald Cutlip, MD, principal investigator of the PzF SHIELD trial and professor of medicine at Beth Israel Deaconess Medical Center and Harvard Medical School, said in the release. “Given the observed low rates of stent thrombosis and target lesion revascularization that need to be confirmed in future studies, the COBRA PzF stent system may hold potential unique benefit for these patients.”

The stent is designed to improve coronary luminal diameter in patients with symptomatic ischemic heart disease due to novo lesions in native coronary arteries with reference vessel diameter of 2.5 mm to 4 mm and lesion length 24 mm or less, including patients with diabetes, according to the release.

The company stated it is currently performing further study on the COBRA PzF stent in COBRA REDUCE, a randomized controlled trial to evaluate the efficacy of the stent in reducing bleeding compared with DES and to determine if 14-day DAPT after use of the stent is feasible.

Disclosure: Cutlip reports receiving research support from Boston Scientific, CeloNova BioSciences and Medtronic.