FDA approves investigative device exemption trial for Cobra PzF


CeloNova BioSciences announced that the US Food and Drug Administration (FDA) has granted approval to start an investigative device exemption (IDE) trial for its Cobra PzF coronary stent system.

According the company, the Cobra PzF coronary stent is made of cobalt chromium super alloy and is coated with an advanced nano-thin coating of Polyzene-F polymer, which is approximately 100 times thinner than coating on currently available commercial coronary stents.

“The Polyzene-F nano-coating technology, when combined with a next-generation stent and delivery system, is a potential game-changer,” says Jane Ren, CeloNova BioSciences chief technology officer. “Early indications are that the nano-coated stent leads to a much faster, natural healing of the artery and also would reduce the need for long term blood-thinning medication.”

“In addition to the IDE trial, we are also undertaking new scientific studies to expand our clinical evidence,” Ren adds.

The IDE trial will study the Cobra PzF, Polyzene-F stent technology in patients with heart disease. It will enrol patients in multiple research centres across the United States and in Europe. The trial is being led by researcher, Donald Cutlip, of Harvard Medical School, Boston, USA.