CeloNova Announces Clinical Results From Pivotal PzF SHIELD Trial

February 2, 2017—CeloNova BioSciences, Inc. recently announced the publication of primary endpoint results from its global, multicenter PzF SHIELD clinical trial evaluating the company's Cobra Polyzene-F (PzF) nanocoated coronary stent. The 9-month findings were published by Donald E. Cutlip, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2017;10:160–167).

According to the company, the PzF SHIELD study demonstrated that the Cobra PzF stent met prespecified performance goals for both the primary endpoint of target vessel failure and the secondary endpoint of angiographic late lumen loss at 9 months postintervention.

The single-arm, nonrandomized study, which was conducted at 35 centers in the United States and other countries, enrolled a total of 296 patients with symptomatic ischemic heart disease who received treatment with the Cobra PzF stent. Many of the patients had comorbidities including diabetes (33.7%), previous percutaneous coronary intervention (30.4%), and atrial fibrillation (12.2%).

Dr. Cutlip, who is Principal Investigator of the trial, commented, “We are pleased to have met our primary endpoint and are reassured by low rates of stent thrombosis and target lesion revascularization that need to be confirmed in future studies. The results hold potential unique benefit for patients who may not be candidates for drug-eluting stents or longer-term dual antiplatelet therapy, a continued unmet clinical need.”

CeloNova advised that the Cobra PzF stent combines a highly deliverable cobalt chromium platform with the company's PzF nanothin polymer that is designed to be durable and elastic, as well as biocompatible to act as a barrier between metal, blood, and circulating elements.

In the United States, the Cobra PzF nanocoated coronary stent is an investigational device and is not approved for sale. The trial was conducted under an investigational device exemption from the US Food and Drug Administration. The Cobra PzF received CE Mark approval in 2012 and was launched in Europe and the Middle East in 2013.

Currently, the company is further studying the Cobra PzF stent in the COBRA-REDUCE randomized controlled trial that will evaluate the safety and efficacy of the device to reduce the need for long-term dual antiplatelet therapy in patients to 14 days who are at high risk for bleeding and require treatment for coronary artery disease.