CeloNova BioSciences said today it won FDA approval for its Cobra PzF nanocoated coronary stent system.
The device is now cleared with indications for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries with a reference vessel diameter of 2.5-4mm and lesion length of less than or equal to 24mm.
Approval of the device came based on findings from the comapny’s pivotal PzF shield clinical trial, which demonstrated no stent thrombosis and clinically driven target lesion revascularization of 4.6%, the San Antonio, Texas-based company said.
“The stent’s Polyzene-F nanocoating is truly cutting-edge with good biocompatibility. We continue to observe its thrombo-resistant and rapid endothelialization properties, which give us confidence to believe that Cobra PzF is a good stent option for patients who are at a high-risk for bleeding following coronary intervention,” Dr. Renu Virmani of Gaithersburg, Md.’s CV Path Institute said in a prepared statement
CeloNova said it is studying the device in its Cobra Reduce trial, which began enrollment in February. The trial aims to explore whether the Cobra PzF stent can reduce bleeding when compared to drug eluting stents by shortening the duration of dual anti-platelet therapy to 14 days in patients at high-risk for bleeding who require treatment for coronary artery disease.
“There continues to be an unmet clinical need for patients who may not be candidates for drug-eluting stents or longer term dual antiplatelet therapy. Given the observed low rates of stent thrombosis and target lesion revascularization that need to be confirmed in future studies, the Cobra PzF stent system may hold potential unique benefits for these patients,” principal investigator Dr. Donald Cutlip of Boston’s Beth Israel Deaconess Medical Center said in prepared remarks.
“Today’s FDA approval of the Cobra PzF Stent System marks a significant milestone for our company, as we bring a new category of stent with proven clinical promise to the U.S. market. We look forward to working with physicians throughout the country to integrate COBRA PzF into their care plans for the growing number of patients who would benefit from very low stent thrombosis, low TLR and a minimum 30 day DAPT regimen,” acting CEO Dennert Ware said in a press release.
In January, CeloNova 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.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.