We’ve covered the CeloNova Bioscience‘s Polyzene-F Coronary Stent in the past. Considered by some to be the next generation substitute for drug-eluting stents, Polyzene®-F nanothin surface coating (also known as poly[bis(trifluroexthoxy)phosphazene] ) has a lot potential clinical advantages, such as its supposed biocompatibility and an anti-inflammatory potential. We thought that the Newnan, GA based company deserved an update though, as yesterday CeloNova announced a ‘live’ demonstration of the Catania Stent traversing a chronically (>30 days) and totally occluded artery. The live case symposium will take place October 15, 2008 at the Paris Cardiovascular Interventions (Francophone) Congress. According to the company, the CATANIA™ Coronary Stent System carries a CE Mark and is currently available for sale in Europe. The company rep tells Medgadget that CeloNova’s products have not been FDA approved, and that the company has not made a business decision yet to try to bring its stent technology to the US.
From the press release:
The CATANIA™ Stent was selected for this live case because Polyzene®-F makes it highly lubricious and delivers low restenosis rates, excellent anti-thrombosis rates, and other clinical benefits that approach or, in some cases, may exceed those of DES, while addressing some of the significant ongoing concerns with current DES technology such as product cost, risk for thrombosis, and serious challenges associated with costly long-term dual anti-platelet therapy following treatment.
“The CATANIA™ Stent has superb pushability, trackability, and flexibility. You can feel that the Polyzene®-F surface is slicker than other stents,” said Thierry Corcos, MD, FACC, FAHA, FESC, FSCAI, Service de Cardiologie, Clinique Turin, Paris, France. “For the live case, we want to really test the CATANIA™ Stent’s capabilities in a challenging anatomy, because of the clinical evidence that Polyzene®-F nanocoating prevents thrombosis, restenosis and reocclusion. Based on my experience, I believe the CATANIA™ Stent is an ideal choice for treating coronary artery disease, including chronic total occlusions.”
The proprietary nanothin, highly lubricious Polyzene®-F is a synthesized, inorganic, biocompatible polymer that is anti-thrombotic, anti-inflammatory, bacterial-resistant, and essentially cloaks the device’s presence from the body to promote healthy endothelial cell growth without stimulating platelet activation. This unique combination of stent and surface treatment effectively creates a new and different class of stent that does not require long-term dual anti-platelet therapy.