Clearance by FDA to nanocoated coronary stent of CeloNova

CeloNova Biosciences, a medical device industry, has designed a nanocoated coronary stent for treating patients with obstructive coronary artery disease. This device can be a substitute for patients for whom long-term antiplatelet therapy or drug-eluting stents is not suitable. The Food and Drug Administration has given clearance to this novel device.

The Cobra PzF stent is designated to enhance the coronary arteries’ luminal diameter in symptomatic ischemic heart disease patients, which is resulted from new lesions. Although rare, device thrombosis, that is, the development of a blood clot in a stented vessel that inhibits the blood flow, is a severe problem of stenting. Long-term dual antiplatelet therapy prevents platelets from fusing together and creating a clot, at the same time increasing the risk of bleeding.

Cobra PzF stent is made of cobalt chromium and has a polyzene-F nanocoating. The polyzene-F nanocoating is demonstrated to have thromboresistant, anti-inflammatory, and healing effects in the preclinical studies. The device needs dual antiplatelet therapy for 30 days after stenting in comparison to a minimum 6 months suggested for drug-eluting stents.

Renu Virmani said, “The polyzene-F nanocoating of the stent is actually revolutionary with good biocompatibility. We keep on studying its rapid endothelialization and thromboresistant properties that give us assurance to consider that this device is a good stent choice for those who have a higher risk for bleeding after coronary intervention.

The clearance was earned on the basis of trials conducted at 35 sites in the United States that enrolled 296 patients. The study observed no stent thrombosis after a 9-month follow-up duration. It also demonstrated a low target lesion revascularization rate.

Donald Cutlip, Principal Investigator, said “As observed in the study, the low rates of target lesion revascularization and stent thrombosis should be validated in further studies. The COBRA PzF stent device may show possible unique advantages for these patients.”

CeloNova will be conducting one more trial to evaluate whether the Cobra PzF stent can assist in reducing the bleeding with a shorter duration of dual antiplatelet therapy, that is, 14 days, in comparison to the drug-eluting stents.

Thus, this device can be helpful for patients with high risk of bleeding after coronary intervention. Isn’t it?

Vaibhav Bhosale undertook the post of Content Writer at Medical Device News in November 2016, following a 1.2-year of experience as an Project Lead; Instructional Writer at eNyota Learning Pvt. Ltd. His immense interest in reading brought him in this field. He can be reached at vaibhav@medicaldevicenews.net