FDA Grants Conditional Approval to CeloNova to Study Stent System

CeloNova BioSciences has received conditional approval from the FDA to start an investigational device exemption trial to study the Cobra PzF coronary stent system in patients at high risk of bleeding.

The trial will determine whether the stent can help reduce bleeding, compared to drug eluting stents, by shortening dual antiplatelet therapy to 14 days in patients treated with oral anticoagulation and undergoing PCI.

According to the San Antonio, Texas-based company, the stent features a Polyzene-F nano-coating and an advanced thin-strut design.

The stent system received CE Mark approval in 2012 and launched in Europe and the Middle East in 2013. — Michael Cipriano