CeloNova’s nanocoated coronary stent wins FDA nod

The FDA approved CeloNova Biosciences’ nanocoated coronary stent for the treatment of obstructive coronary artery disease. The device could be an alternative for patients who are unsuitable for drug-eluting stents or long-term antiplatelet therapy.

The Cobra PzF stent is indicated to improve the luminal diameter of coronary arteries in patients with symptomatic ischemic heart disease caused by new lesions. It earned a CE mark in 2012.

While uncommon, device thrombosis—the formation of a blood clot in a stented vessel that blocks blood flow—is a serious complication of stenting. Long-term dual antiplatelet therapy (DAPT) stops platelets from sticking together and forming a clot, but it can also raise the risk of bleeding.

Made of cobalt chromium, the Cobra PzF stent has a Polyzene-F nanocoating, which was shown in preclinical studies to have anti-inflammatory, thromboresistant and healing effects, CelnoNova said in a statement. The device requires DAPT for 30 days following stenting, compared to the 6-month minimum recommended for drug-eluting stents.

“The stent’s Polyzene-F nanocoating is truly cutting-edge with good biocompatibility,” said Renu Virmani, M.D., president of the CV Path Institute in Gaithersburg, MD, in the statement. “We continue to observe its thrombo-resistant and rapid endothelialization properties, which give us confidence to believe that COBRA PzF is a good stent option for patients who are at a high-risk for bleeding following coronary intervention.

The FDA nod is based on a 296-patient pivotal trial that is taking place at 35 U.S. sites. At a 9-month follow-up, there was no stent thrombosis and a low target lesion revascularization rate of 4.6%, according to the statement.

“There continues to be an unmet clinical need for patients who may not be candidates for drug-eluting stents or longer term dual antiplatelet therapy,” said Donald Cutlip, M.D., principal investigator and professor of medicine at Beth Israel Deaconess Medical Center and Harvard Medical School, in the statement. “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 benefits for these patients.”

CeloNova is running another trial, which will assess whether the Cobra PzF stent can help decrease bleeding with an even shorter period of DAPT—14 days—when compared to drug-eluting stents.