The US Food and Drug Administration (FDA) has approved the Cobra PzF nanocoated coronary stent system developed by Texas medical device maker CeloNova BioSciences.
Approval of the nanocoated Cobra PzF coronary stent system from the regulator comes on the backdrop of the PzF Shield clinical trial whose primary safety and effectiveness endpoints were met in the ninth month of follow-up.
The clinical study of Cobra PzF coronary stent system did not show stent thrombosis besides registering minimal clinically driven target lesion revascularization (TLR) of 4.6%.
The nano-thin polymer-coated Cobra PzF coronary stent system, which is highly biocompatible, would need a minimum of 30 days of dual antiplatelet therapy (DAPT) regimen post intervention.
Dennert Ware, Executive Chairman and acting CEO, CeloNova Biosciences commented: “Today’s FDA approval of the COBRA PzF Stent System marks a significant milestone for our company, as we bring a new category of stent with proven clinical promise to the U.S. market.
“We look forward to working with physicians throughout the country to integrate COBRA PzF into their care plans for the growing number of patients who would benefit from very low stent thrombosis, low TLR and a minimum 30 day DAPT regimen.”
Cobra PzF coronary stent system improves coronary luminal diameter in patients, including diabetic patients.
The coronary stent system from CeloNova can also be placed in the coronary arteries for the treatment of symptomatic ischemic heart disease patients. It applies for patients whose disease was caused by de novo lesions in native coronary arteries with reference vessel diameter (RVD) of 2.5-4.0mm and lesion length of ≤24mm.