FDA Grants Approval to CeloNova Biosciences’ COBRA PzF Stent System

San Antonio–based, CeloNova Biosciences has received FDA approval of its Cobra PzF nano-coated coronary stent system.

The stent is 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 of greater or equal to 24mm.

The stent was awarded CE Mark approval in 2012. — Cynthia Jessup