'New Class' Of Coronary Stent Shows Sustained 12-Month Benefit

Main Category: Medical Devices / Diagnostics
Also Included In: Cardiovascular / Cardiology
Article Date: 19 Mar 2009 - 0:00 PST

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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 BMS and DES. These conclusions, based on 12-month data from the ATLANTA Trial, were published in the latest issue of the Journal of the American College of Cardiology: Cardiovascular Interventions.

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. The trial was sponsored by CeloNova BioSciences, Inc., manufacturer of the CATANIA™ stent.

At 12 months, in an 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 polymer is, without any doubt, the main reason for the great results we have obtained which is why I chose the CATANIA™ stent to implant in my very best friend," said Corrado Tamburino, MD, PhD, 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 12-month ATLANTA data indicate that the CATANIA™ stent with Polyzene®-F is truly a new and promising class of stent."

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.

"Economically, this stent has great merit, because it costs less than DES, does away with the costs associated with long-term dual antiplatelet therapy, and prevents repeat procedures, said Thomas A. Gordy, President and Chief Executive Officer of CeloNova. "The investigators found the CATANIA™ stent to be flexible in even the most tortuous anatomy. The Polyzene®-F surface treatment is so slick that it improves pushability and hides the stent from the body's defenses, which reduces platelet aggregation and the potential for thrombosis."

About CeloNova BioSciences, Inc.

Headquartered in Newnan, GA, USA, CeloNova develops novel surface treatments including the Company's proprietary material, Polyzene®-F, a lubricious, anti-thrombotic, anti-inflammatory, and bacterial-resistant coating for any implanted medical device. Polyzene®-F can be applied to or mixed with other substances in thickness from less than 40 to more than 200 nanometers on polymeric, metal, and ceramic substrates for a diverse range of customized bioscience and industrial applications. CeloNova's current products include Embozene™ Color-Advanced Microspheres and the CATANIA™ Stent. The CATANIA™ stent is not available in the U.S. For more information, please visit http://www.celonova.com.

Source
CeloNova BioSciences, Inc.

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