'New Class' of Stent with Polyzene(R)-F Surface Treatment Maximizes Endothelialization; Reduces Restenosis, Thrombogenicity, Need for Long-Term Dual Antiplatelet Therapy
WASHINGTON, Oct. 13 /PRNewswire/ -- Clinical investigators at today's "Innovative Devices and Futuristic Therapies" session during the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation, presented 12-month follow-up data from the ATLANTA Trial. The results include zero percent thrombosis in patients discontinuing dual anti-platelet therapy after only 30 days.
The ATLANTA Trial is a first-in-man (FIM), prospective, single center, non-randomized, single-arm study involving 55 patients (76 lesions) treated with the CATANIA(TM) Coronary Stent System with NanoThin Polyzene(R)-F surface modification for symptomatic ischemic heart disease due to de novo, obstructive lesions of native coronary arteries. The trial was sponsored by CeloNova BioSciences, Inc., maker of the CATANIA(TM) stent.
At 12 months, in an unusually complex FIM patient population, the results showed zero (0.0) percent stent thrombosis (Academic Research Consortium, or ARC-defined), death, myocardial infarction, stroke, or coronary artery bypass graft. Target lesion revascularization was 10.9 percent (only 3.6 percent clinically driven, 7.3 percent non-clinically driven), with a binary restenosis rate of 6.8 percent (five of 74 lesions analyzed at twelve months). Of note, all patients stopped dual anti-platelet therapy after 30 days, but continued aspirin (100 mg/d) throughout the 12-month period.
The acute angiographic and procedural success rate in the ATLANTA Trial was 100 percent. Independent core laboratories analyzed quantitative coronary angiography and intravascular ultrasound (IVUS) data for all patients immediately after stent implantation and at 6-month follow-up. Further analysis of 1,904 cross sections (19,028 struts) by investigators using Optimal Coherence Tomography at baseline and again at 6-month follow-up in a subset of 15 randomly selected patients revealed complete endothelialization and 99.5 percent stent strut coverage.
"Every clinician is aware of the questions and issues surrounding drug-eluting stents and the increased risk of late and very late stent thrombosis, malapposition, inflammatory or hypersensitivity reactions, as well as the economic impact of maintaining long-term dual antiplatelet therapy," 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(TM) stent with Polyzene(R)-F is truly a new and promising class of stent. Further, the CATANIA(TM) stent may offer an improved safety profile as evidenced by the fact that there were no deaths, myocardial infarctions, or stent thrombosis in a significantly complex patient population. Economically, this stent has merit, because it does away with the costs associated with long-term dual antiplatelet therapy."
The rapid-exchange, cobalt-chromium CATANIA(TM) stent carries a CE Mark and is currently available for sale outside of the United States in 60 sizes, in lengths from 8-38mm and in diameters from 2.0-4.0mm. "The CATANIA(TM) stent represents the next evolution in angioplasty treatment," said Thomas A. Gordy, President and Chief Executive Officer, CeloNova Biosciences, Inc. "Physicians, health care systems, and insurance programs need breakthroughs, not devices that are marginally better than what already exists. Marginal improvements advance competition; we need to be advancing medicine first."
The CATANIA(TM) stent surface has a thin (35-40 nanometers) surface treatment of highly lubricious Polyzene(R)-F, 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.
"We found the CATANIA(TM) stent to be highly deliverable, trackable, and flexible in even the most tortuous anatomy," said Dr. Tamburino. "The Polyzene(R)-F surface treatment endows the stent with exceptional qualities that not only create a highly lubricious system that inspires user confidence and improved pushability, but also hides the stent from the body's defenses, which reduces platelet aggregation and the potential for thrombosis."
ABOUT NANOTHIN POLYZENE(R)-F
The proprietary NanoThin Polyzene(R)-F polymer can be applied to or mixed with other substances to allow for a diverse range of bioscience and industrial applications on a multitude of substrates, including other polymers, metals, and ceramics. Medical devices coated with Polyzene(R)-F do not cause a negative reaction in the body when introduced, eliciting a normalized and positive bodily response. Polyzene(R)-F can be customized for the desired application and applied in a variety of ways including as a coating, extrusion, weaving, or electro-spinning ranging in thickness from less than 40 nanometers to more than 200 nanometers. The base substrate will be endowed with the properties of the polymer.
About CeloNova BioSciences, Inc.
Headquartered in Newnan, Georgia, CeloNova BioSciences, Inc., is a developer of novel medical devices that are enhanced by one of the Company's proprietary materials, Polyzene(R)-F. Polyzene(R)-F is highly lubricious, anti-thrombotic, anti-inflammatory, and bacterial-resistant making it an ideal surface treatment for implanted medical devices. The Company's current products include Embozene(TM) Color-Advanced Microspheres and the CATANIA(TM) Coronary Stent System with NanoThin Polyzene(R)-F. Neither product is currently approved for use in the United States. Other innovative devices are currently in the company's developmental pipeline. For more information, please visit www.celonova.com.
CONTACT: Robert J. Murphy or David Patti, both of The Storch-Murphy Group,
Ltd., for CeloNova BioSciences, Inc., +1-908-276-0777
Web site: http://www.celonova.com/