The FDA has approved a nano-coated coronary stent system—CeloNova Biosciences’ Cobra PzF—for use in percutaneous coronary intervention (PCI), specifically to improve coronary luminal diameter. The approval, a press release reports, is based on the PzF SHIELD clinical trial, which met its primary safety and effectiveness endpoints at 9-month follow-up. The trial showed that the Cobra PzF device was not associated, at this time point, with stent thrombosis and that the rate of clinically-driven target lesion revascularisation was low (4.6%).
According to the press release, the stent is coated with a proprietary nano-thin polymer that is designed to be highly biocompatible and requires a minimum 30-day dual antiplatelet therapy (DAPT) regimen following intervention. It, the press release reports, combines a unique, highly deliverable cobalt chromium platform design with a proprietary polyzene-F nano-thin polymer. When tested in preclinical studies, the ultra-pure, nano-thin characteristics of polyzene-F nanocoating have shown thromboresistant, anti-inflammatory and rapid healing effects.
Following the FDA approval, the Cobra PzF stent is now indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus with symptomatic ischaemic heart disease due to de novo lesions in native coronary arteries (with reference vessel diameter of 2.5-4mm and lesion length of ≤24mm).
Donald Cutlip (Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, USA), principal investigator of the SHIELD trial, says: “There continues to be an unmet clinical need for patients who may not be candidates for drug-eluting stents or longer term DAPT. Given the observed low rates of stent thrombosis and target lesion revascularization—which need to be confirmed in future studies— the Cobra PzF stent system may hold potential unique benefit for these patients.”
At present, CelaNova is further studying the Cobra PzF stent in the COBRA REDUCE trial, which began enrolment in February 2016. This randomised controlled trial will evaluate whether the COBRA PzF stent, with its novel Polyzene-F nanocoating and advanced thin-strut design, can help reduce bleeding as compared to drug-eluting stents, by shortening the duration of DAPT to 14 days in patients who are at high-risk for bleeding and require treatment for coronary artery disease.