FDA grants approval to CeloNova’s coronary stent system

1 March 2017 (Last Updated March 1st, 2017 18:30)

The US Food and Drug Administration (FDA) has granted regulatory approval to US-based medical device firm CeloNova BioSciences' nanocoated coronary stent system COBRA PzF.

The US Food and Drug Administration (FDA) has granted regulatory approval to US-based medical device firm CeloNova BioSciences' nanocoated coronary stent system COBRA PzF.

COBRA PzF features a deliverable cobalt chromium platform design combined with a proprietary Polyzene-F nano-thin polymer, which is designed to be durable, elastic and biocompatible to act as a barrier between metal, blood and circulating elements.

Pre-clinical studies showed that the polymer's ultra-pure, nano-thin properties contribute to thrombo-resistant, anti-inflammatory and rapid healing effects.

"COBRA PzF is said to improve coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries."

The new stent is said to require a minimum 30 day dual antiplatelet therapy (DAPT) regimen after intervention.

COBRA PzF is said to improve coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries.

The FDA approval is based on findings from a PzF SHIELD clinical trial.

The trial results indicated that the stent has met its primary safety and effectiveness endpoints at nine month follow-up, with no stent thrombosis and low-clinically driven target lesion revascularisation.

Principal investigator of the study, Beth Israel Deaconess Medical Center and Harvard Medical School in Boston professor Donald Cutlip said: “Given the observed low-rates of stent thrombosis and target lesion revascularisation that need to be confirmed in future studies, the COBRA PzF stent system may hold potential unique benefits for these patients.”

The COBRA PzF stent is being further assessed in the randomised controlled COBRA REDUCE trial to evaluate its ability to minimise bleeding in patients who are at high-risk for bleeding and require treatment for coronary artery disease.

The coronary stent has secured CE mark in 2012 and was launched in Europe and the Middle East in 2013.