CeloNova BioSciences yesterday released data from the Shield trial of its Cobra PzF nanocoated coronary stent, announcing the trial met its primary and secondary endpoints.
Results from the study were published in the Journal of the American College of Cardiology: Cardiovascular Interventions this month.
The Cobra PzF coronary stent has a novel Polyzene-F nano-coating and thin-strut design, which CeloNova says can reduce bleeding compared to drug eluting stents and shortens the duration of dual antiplatelet therapy by up to 2 weeks.
The San Antonio, Texas-based company said its Cobra PzF stent met its primary endpoint of target vessel failure and its secondary endpoint of angiographic late lumen loss at 9-months post-intervention.
“We are pleased to have met our primary endpoint and are reassured by low rates of stent thrombosis and target lesion revascularization that need to be confirmed in future studies. The results hold potential unique benefit for patients who may not be candidates for drug-eluting stents or longer term dual antiplatelet therapy, a continued unmet clinical need,” principal investigator Dr. Donald Cutlip of Beth Israel Deaconess Medical Center and Harvard Medical School said in prepared remarks.
The trial included 296 patients with symptomatic ischemic heart disease, including a significant percentage of patients with co-morbidities. A total of 33.7% of the patients had diabetes, 30.4% had prior percutaneous coronary interventions and 12.2% had atrial fibrillation.
CeloNova touted the trial, which was conducted under an FDA investigational device exemption which it won last September, as the 1st to clinically evaluate nanocoated stents in the US.
“Continued investments in our clinical study programs underscore CeloNova’s commitment to develop an innovative stent platform that transforms the way we approach safety in the treatment of coronary artery disease. With this pivotal PzF Shield study primary endpoint complete, we have submitted the data to the FDA for review,” exec chair & acting CEO Dennert Ware said in a prepared statement.
The company said it is continuing to study the device in the Cobra Reduce trial, which will evaluate the safety and efficacy of the stent to reduce the need for long-term dual antiplatelet therapy in patients at high risk for bleeding at 14 days.
Last November, Boston Scientific (NYSE:BSX) said it agreed to pay $70 million up front for CeloNova’s interventional radiology business, including its drug-eluting microsphere technology for chemotherapy and spherical embolic products for treating uterine fibroids and other conditions.
The deal also includes an unspecified amount tied to regulatory and sales milestones, Marlborough, Mass.-based Boston Scientific said.