CeloNova BioSciences has completed patient enrolment in the global, multicentre IDE trial for its Cobra PzF stent. Completed enrolment was ahead of schedule and supports submission for FDA approval of the novel Cobra PzF stent with its advanced, nano-thin coating of Polyzene-F polymer.
“Completion of enrolment ahead of schedule suggests that there is very high interest in the disruptive potential of our stent,” stated Martin Landon, chief executive officer of CeloNova BioSciences.
“We anxiously await the final study results and look forward to a stent that potentially meets an unmet need for patients who are unable or unwilling to be compliant with long term dual anti-platelet therapy (DAPT),” said principal investigator Donald Cutlip, of the Harvard Medical School in Boston, USA.
“The Polyzene-F nano-coating may make the stent surface resistant to thrombus and may help reduce inflammation,” said CeloNova chief technology officer Jane Ren. “Furthermore, the Cobra PzF stent’s advanced thin strut design may help minimise vessel wall injury, and may enable a more rapid and natural healing. We look forward to generating the data that will allow us to bring to market a product that may significantly improve patient care, while reducing cost, across the full care continuum.”