FDA Approves IDE to Study CeloNova's Cobra PzF Coronary Stent

March 18, 2014—CeloNova BioSciences, Inc. (San Antonio, TX) announced that the US Food and Drug Administration (FDA) has granted approval to start an investigational device exemption (IDE) trial for its Cobra PzF coronary stent system.

The IDE trial will enroll patients in multiple research centers across the United States and in Europe under the leadership of Principal Investigator Donald Cutlip, MD, of Harvard Medical School in Boston, Massachusetts.

In CeloNova’s press release, Dr. Cutlip commented, “We are excited to move ahead with the study of this novel device in a clinical trial designed for initial approval in the United States. We also look forward to subsequent studies that will be designed to test what appear to be unique safety features of the device.”

According to the company, the Cobra PzF coronary stent is composed of a cobalt chromium super alloy and is coated with a nano-thin coating of Polyzene-F polymer, which is approximately 100 times thinner than the coating on currently available commercial coronary stents. CeloNova’s Cobra PzF stent builds on and improves upon earlier-generation Polyzene-F stents that have been studied with results published in scientific journals.