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# FDA Approves CeloNova Cobra NanoCoated Stent
- URL: https://www.fdaweb.com/fda-approves-celonova-cobra-nanocoated-stent/
- Published: 2017-03-01T12:00:00.000Z
- Updated: 2026-09-14T22:09:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138096

FDA has approved a CeloNova BioSciences PMA for its first-in-class Cobra PzF NanoCoated Coronary Stent System, indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to *de novo* lesions in native coronary arteries with reference vessel diameter of 2.5-4.0mm and lesion length less-than 24mm. The company says the device is coated with a proprietary nano-thin polymer that is designed to be highly biocompatible, and it requires a minimum 30-day dual antiplatelet therapy regimen following intervention. Approval was based on findings from the pivotal PzF SHIELD clinical trial that demonstrated no stent thrombosis and low clinically driven target lesion revascularization of 4.6%, the company says.