FDA Clears NanoCoated Coronary Stent System
CeloNova Biosciences received FDA approval of its COBRA PzF nanocoated coronary stent system, which uses data capture software developed by DSG.
The stent is designed to improve coronary luminal diameter in patients with symptomatic ischemic heart disease, including diabetics, due to de novo lesions in native coronary arteries with reference vessel diameter of 2.5 mm to 4 mm and lesion length 24 mm or less.
The stent is coated with a biocompatible proprietary nanothin polymer which requires a minimum 30-day dual antiplatelet therapy regimen after intervention. — Cynthia Jessup