CeloNova BioSciences, Inc., today announced that the U.S. Food and Drug Administration (FDA) has granted approval to start an investigative device exemption (IDE) trial for its novel coronary stent system – the Cobra PzF™ coronary stent system. Coronary stents are thin wire mesh devices used in minimally invasive heart surgery to prop open clogged blood vessels of the heart.
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. 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 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 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,” she said.
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 the distinguished researcher, Dr. Donald Cutlip, of Harvard Medical School, Boston.
“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 Dr. Cutlip. “We also look forward to subsequent studies that will be designed to test what appear to be unique safety features of the device.”
CeloNova BioSciences CEO Martin Landon said, “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.”
The company announced on March 11 that the FDA had issued 510(k) clearance expanding CeloNova BioSciences’ 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 (UFE) – as an alternative to a hysterectomy operation.