CeloNova BioSciences has announced that the US 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.
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.
CeloNova BioSciences chief technology officer Dr Jane Ren noted the Polyzene-F nano-coating technology, when combined with a next-generation stent and delivery system, is a potential game-changer.
"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," Dr Ren added.
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 US and in Europe. The trial is being led by the distinguished researcher, Dr Donald Cutlip, of Harvard Medical School, Boston.
The company announced on 11 March 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 – as an alternative to a hysterectomy operation.