Global medical device firm CeloNova BioSciences has started a clinical trial to evaluate the Cobra PzF nanocoated coronary stent (NCS) system in patients at high risk of bleeding.
The company recently received conditional approval from the US Food and Drug Administration (FDA) for the Cobra Reduce trial to assess the safety and efficacy of the NCS system in patients at high risk of bleeding.
CeloNova, which has enrolled the trial’s first patient at the Northshore University Hospital in New York, plans to recruit around 844 patients at the study in the US and Europe.
CeloNova Biosciences president and CEO Martin Landon said: "The Cobra PzF stent is designed to satisfy the unmet market need for a device that reduces the need for long-term blood-thinning agents, but with the possibility of lower restenosis rates.
"With the enrollment of the first patient in this randomized trial, led by Professor Kastrati, one of the leading researchers in the world, we have taken a very important next step in demonstrating the positive patient benefits of our technology."
According to the company, the trial is the firm’s second major interventional cardiology study and follows a successful early enrollment completion of the PzF Shield study last year.
The firm will use the results from the PzF Shield study to complete its PMA application to the FDA for the Cobra PzF stent.
Cobra PzF stent features thin struts thar are made by using cobalt chromium super alloy, as well as coated with an advanced Polyzene-F nanocoating that is expected to reduce fibrinogen and platelet adhesion.
The stent platform is designed to minimize vessel wall injury and lower inflammation, according to the company.