Feb 20 2015
CeloNova BioSciences, Inc. announced completion of patient enrollment in the global, multi-center IDE trial for its COBRA PzF stent. Completed enrollment 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.
“We are excited to have completed this important milestone, with the involvement of outstanding study investigators under the leadership of Principal Investigator Professor Donald Cutlip, MD, of the Harvard Medical School in Boston, Massachusetts and Co-Principal Investigator Professor Sigmund Silber, MD, PhD of the University of Munich, Germany,” stated Martin Landon, CEO of CeloNova BioSciences. “Completion of enrollment ahead of schedule suggests that there is very high interest in the disruptive potential of our stent.”
“We wish to thank and congratulate the research teams in all participating centers for their hard work,” said Professor Cutlip. “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).”
“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 minimize 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.”
Source: http://celonova.com/