News | March 17, 2009

De Novo Coronary Lesions May Benefit from New Stent Treatment, Study Shows

March 17, 2009 – Twelve-month data from the ATLANTA Trial shows that the CATANIA Coronary Stent System with NanoThin Polyzene-F offers sustained benefit in the treatment of de novo coronary lesions and maximizes endothelialization, while reducing restenosis, thrombogenicity, and the need for long-term dual-antiplatelet therapy.

The CATANIA Stent may be an alternative to both bare metal stents (BMS) and drug-eluting stents (DES). These conclusions were published in the latest issue of the Journal of the American College of Cardiology: Cardiovascular Interventions.

Sponsored by CeloNova BioSciences, manufacturer of the CATANIA stent, the ATLANTA Trial is a first-in-man (FIM), prospective, single center study involving 55 patients treated with the CATANIA Stent for symptomatic ischemic heart disease due to de novo, obstructive lesions of native coronary arteries.

At 12 months, in a reportedly unusually complex FIM patient population, the results showed zero (0.0) percent stent thrombosis, death, myocardial infarction, stroke, or coronary artery bypass graft. Target lesion revascularization was 10.9 percent (only 3.6 percent clinically driven), with a binary restenosis rate of 6.8 percent. All patients stopped dual anti-platelet therapy after 30 days. The procedural success rate was 100 percent.

Independent laboratories analyzed coronary angiography and intravascular ultrasound data for all patients immediately after stent implantation and at 6-months. Analysis of 19,028 struts using optimal coherence tomography in a subset of 15 randomly selected patients revealed complete endothelialization and 99.5 percent stent strut coverage.

"CeloNova has started a scientific revolution involving the way physicians think about BMS and DES. I can definitely assert that Polyzene-F is innovative, effective in several aspects, unique and striking. The 12-month ATLANTA data indicate that the CATANIA stent with Polyzene-F is truly a new and promising class of stent," said Corrado Tamburino, M.D., Ph.D., FESC, FSCAI, FSICI-GISE, professor of cardiology and chief of the cardiovascular department, Ferrarotto Hospital, Catania, Italy, and lead investigator in the ATLANTA Trial.

The rapid-exchange, cobalt-chromium CATANIA stent is currently available for sale in Europe in 60 sizes, in lengths from 8-38mm and in diameters from 2.0-4.0mm. The CATANIA stent surface has a 35-40 nanometer surface treatment of Polyzene-F, an inorganic, biocompatible polymer that is anti-thrombotic, anti-inflammatory, bacterial-resistant, lubricious, and essentially cloaks the device's presence from the body to promote healthy endothelial cell growth without stimulating platelet activation.

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