Enrollment Complete in SHIELD Trial of CeloNova's Cobra PzF Stent

February 19, 2015—CeloNova BioSciences, Inc. announced completion of patient enrollment in the global, multicenter PzF SHIELD trial for its Cobra PzF stent, which features a nano-thin coating of Polyzene-F (PzF) polymer. Enrollment was completed ahead of schedule, noted the company.

The study was conducted under an investigational device exemption from the US Food and Drug Administration (FDA) to support submission for FDA approval of the Cobra PzF stent in the United States. The PzF nanocoating may make the stent surface resistant to thrombus and may help reduce inflammation, and the device’s thin strut design may help minimize vessel wall injury and may enable a more rapid and natural healing, stated the company.

The study’s principal investigators are Prof. Donald Cutlip, MD, of the Harvard Medical School in Boston, Massachusetts, and Prof. Sigmund Silber, MD, of the University of Munich in Munich, Germany.

In CeloNova’s press release, Prof. Cutlip commented, “We wish to thank and congratulate the research teams in all participating centers for their hard work. 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-antiplatelet therapy.”