NEWNAN, Ga., Dec. 3 /PRNewswire/ -- CeloNova BioSciences, Inc., announced today that it has expanded the areas in which it is commercializing the CATANIA(TM) Coronary Stent System with NanoThin Polyzene(R)-F -- a stent system that has not had any stent thrombosis in clinical studies. It is CE Marked and available for purchase throughout Europe and now some Middle Eastern countries with aggressive world-wide expansion ongoing. Concurrently, CeloNova notes that it has received regulatory approval to increase the shelf life for the stent from two years to three years.
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The CATANIA(TM) Polyzene(R)-F surface treatment is an inorganic polymer that confers superior biocompatibility and lubricity to the substrates it coats. The Polyzene(R)-F treated surface is anti-inflammatory, promotes quick and complete vessel healing, reduces peri-operative and post-procedural platelet activation, and helps to prevent tissue reactions that lead to restenosis.
"After having evaluated the Polyzene(R)-F coating many years ago, it is interesting to see this concept coming back with experimental and initial clinical data quite encouraging toward prevention of stent thrombosis," said Antonio Colombo, MD, Director of the Cardiac Catheterization Laboratory at Columbus Hospital and Chief of Invasive Cardiology at San Raffaele Hospital, both in Milan, Italy, who recently added the CATANIA(TM) stent to his practice.
The 1-year data for the first-in-man (FIM) presented at the recent Transcatheter Cardiovascular Therapeutics conference shows that 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.
"We agree with Albert Einstein who said that we should strive to design solutions that are as simple as possible. The CATANIA(TM) stent, while it is superbly engineered to include the highly developed Polyzene(R)-F, is a simple solution to a complex problem. It has no drugs, no thick polymeric coating, no substance to artificially stimulate cell growth, and no additives. And, it does not force patients to take dual antiplatelet therapies for months on end, further complicating their lives," said Thomas A. Gordy, President and Chief Executive Officer, CeloNova BioSciences, Inc. "The 'CAT(TM)' stent is an elegant, yet simple solution to the problem of clogged arteries."
For more information about CeloNova BioSciences, visit www.celonova.com. To place an order for the CATANIA(TM) stent, call +1 770-502-0304 to reach your local sales representative or e-mail firstname.lastname@example.org.
About CeloNova BioSciences, Inc.
Headquartered in Newnan, near Atlanta, Georgia, CeloNova BioSciences, Inc., is a developer of novel medical devices that are then enhanced by one of the Company's proprietary materials, Polyzene(R)-F. Polyzene(R)-F is highly lubricious, anti-inflammatory, and bacterial-resistant making it an ideal surface treatment for implanted medical devices. The Company's current products include its Embozene(TM) Color-Advanced Microspheres and the CATANIA(TM) Coronary Stent System with NanoThin Polyzene(R)-F. Other innovative devices are currently in the company's developmental pipeline. For more information, please visit www.celonova.com.
Polyzene(R)-F is a synthesized inorganic chemical compound with an extensive array of bioscience and industrial applications that 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.
CONTACT: Robert J. Murphy
CONTACT: Robert J. Murphy of The Storch-Murphy Group, +1-908-276-0777, for
CeloNova BioSciences, Inc.
Web site: http://www.celonova.com/