CeloNova Given Approval to Start IDE Trial for Coronary Stent System

CeloNova BioSciences Inc. today has received approval from the U.S. Food and Drug Administration (FDA) to start an investigative device exemption (IDE) trial for its Cobra PzF coronary stent system.

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 the coating on currently available commercial coronary stents. Earlier generation Polyzene-F stents have been studied and results published in scientific journals. CeloNova’s Cobra PzF stent builds on this knowledge and improves on the earlier generation Polyzene-F stent technology, the company claims.

“The Polyzene-F nano-coating technology, when combined with a next-generation stent and delivery system, is a potential game-changer,” according to Jane Ren, Ph.D., 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 reduces 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.”

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

“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,” said Cutlip. “We also look forward to subsequent studies that will be designed to test what appear to be unique safety features of the device.”

In March, the FDA granted 510(k) clearance to CeloNova’s Embozene microsphere product to include the treatment of uterine fibroids. That approval now gives women suffering from uterine fibroids an important treatment option-–-uterine fibroid embolization-–- as an alternative to a hysterectomy operation.

“Our vision is to bring new, unique and disruptive products to market that significantly improve patient care across the full care continuum. Recent indication expansion for our Embozene product to treat benign tumors in the uterus, as well as this IDE trial approval for our Cobra PzF stent to treat heart disease, are two examples of how we are working to bring significant clinical and economic value to patients and customers,” CeloNova BioSciences CEO Martin Landon said.

Headquartered in San Antonio, Texas, CeloNova Biosciences develops, manufactures and markets a family of interventional cardiology and endovascular products. The devices are developed and manufactured in Carlsbad, Calif., and Ulm, Germany. The company operates regional offices in Germany, France, United Kingdom, the Netherlands and Austria.