Navigation Links
12-Month ATLANTA Trial Data Show Sustained Benefit of Catania(TM) Stent in Treatment of De Novo Coronary Lesions
Date:10/13/2008

'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 http://www.celonova.com.


'/>"/>
SOURCE CeloNova BioSciences, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Long-Term 12-Month Safety Data Presented on ADHD Patch DAYTRANA(TM) (methylphenidate transdermal system)
2. Neurobiological Technologies Announces FDA Agreement to Consolidate Viprinex Phase 3 Trials Accelerating Time to Pivotal Data
3. XTENT Announces Clinical Trial Data to be Presented at Annual Meeting of Transcatheter Cardiovascular Therapeutics Next Week
4. Boston Scientific to Release Broad Range of Clinical Trial Data on the Performance of TAXUS(R) Coronary Stent Systems at TCT 2008
5. SCOLR Pharma Announces Completion of Patient Enrollment and Dosing for Pivotal Clinical Trial Evaluating Extended Release Ibuprofen
6. Boston Scientific Completes Clinical Trial Enrollment for Third-Generation Drug-Eluting Stent
7. Vical Expands Applications of Vaxfectin(R) Adjuvant for Infectious Disease and Cancer Vaccines; 80% to 100% of High-Dose Responders in H5N1 Clinical Trials Still Responding at 6 Months
8. Texas Cardiac Arrhythmia Institute at St. Davids Medical Center Selected to Conduct Clinical Trial for Device to Treat Atrial Fibrillation
9. Study Published in Journal of Clinical Psychiatry Showed Once-Daily VYVANSE(R) (lisdexamfetamine dimesylate) Significantly Improved ADHD Symptoms in One of the Largest Controlled Stimulant Trials in Adults with ADHD
10. Peregrine Pharmaceuticals Completes Patient Enrollment in First Stage of Its Second Bavituximab Phase II Breast Cancer Trial
11. Dendreon Announces Interim Data From Phase 3 PROVENGE IMPACT Trial
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... -- The primary goal of this research is to ... usage of liquid biopsy. Key information the survey seeks ... of liquid biopsy adoption amidst future users - Predominantly ... - Sample inflow to conduct liquid biopsy tests - ... so on. - Correlation analysis of sample type and ...
(Date:2/11/2016)... SAN FRANCISCO , Feb. 11, 2016  Kindred ... focused on saving and improving the lives of pets, ... Technical Section of the New Animal Drug Application (NADA) ... the pivotal field study (KB0120) of Zimeta for the ... by the Company. --> ...
(Date:2/11/2016)... Feb. 11, 2016 Potrero Medical, Inc., the developer ... announce the appointment of George M. Rapier, III , ... Antonio, TX , WellMed is one of the nation,s ... and HMO members in Texas and ... out of his own internal medicine practice, he has been ...
Breaking Medicine Technology:
(Date:2/13/2016)... Salt Lake City, Utah (PRWEB) , ... February 13, 2016 , ... When an ... kids, Host Parents aren’t always sure what they are in for and they are often ... Pairs are more than they were hoping for. This year’s Au Pair of the Year ...
(Date:2/12/2016)... ... , ... Mystic Buddha Publishing House presents Valentine’s Day tips on different forms ... - Dr. Frederick Lenz. , According to Publisher Roger Cantu, “Blue Skies ... teaching and helping others. Valentine’s Day celebrates love in all its forms, and ...
(Date:2/12/2016)... Church, VA (PRWEB) , ... February 12, 2016 , ... CDRH Enforcement Trends: , Back ... http://www.fdanews.com/cdrhenforcementtrends , As Winston Churchill said, “Those who don’t learn from ... will show what to expect when they come knocking this year. But that takes time. ...
(Date:2/12/2016)... CULVER CITY, California (PRWEB) , ... February 12, 2016 , ... ... to announce their participation in Red Carpet Events LA GRAMMY’s Style Lounge Event. Coco ... and healthy way to stay hydrated before the big event. The invitation-only gifting suite, ...
(Date:2/12/2016)... ... , ... Every winter, someone is killed, injured or loses a home in ... part of the Allegheny Health Network, has partnered with Etna Volunteer Fire Department, ... Space” campaign. , “Space Heaters Need Space” aims to bring awareness to ...
Breaking Medicine News(10 mins):