Navigation Links
12-month ATLANTA trial data show sustained benefit of Catania Stent
Date:10/14/2008

WASHINGTON, Oct. 13 -- 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™ Coronary Stent System with NanoThin Polyzene®-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™ 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™ stent with Polyzene®-F is truly a new and promising class of stent. Further, the CATANIA™ 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™ 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™ 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™ stent surface has a thin (35-40 nanometers) surface treatment of highly lubricious Polyzene®-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™ stent to be highly deliverable, trackable, and flexible in even the most tortuous anatomy," said Dr. Tamburino. "The Polyzene®-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."


'/>"/>

Contact: David Patti
dpatti@storchmurphy.com
908-276-0777
The Storch Murphy Group
Source:Eurekalert

Related biology news :

1. DHS Begins Collecting 10 Fingerprints From International Visitors at Hartsfield-Jackson Atlanta International Airport
2. U of M begins nations first clinical trial using T-reg cells from cord blood in leukemia treatment
3. Vitamin E trials fatally flawed
4. Research team says extraterrestrial impact to blame for Ice Age extinctions
5. Trial seeks genetic fingerprint for predicting drug effectiveness
6. The industrial space age
7. Contrast agent trials in swine
8. Small-scale fishing in Mexico rivals industrial fisheries in accidental turtle deaths
9. Study of African traditional medicine will begin world-first clinical trial
10. New model revises estimates of terrestrial carbon dioxide uptake
11. New clinical trial results show how personalized medicine will alter treatment of genetic disorders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/22/2017)... 2017   Neurotechnology , a provider of ... announced the release of the SentiVeillance 6.0 ... facial recognition using up to 10 surveillance, security ... The new version uses deep neural-network-based facial detection ... utilizes a Graphing Processing Unit (GPU) for enhanced ...
(Date:3/22/2017)... 21, 2017 Vigilant Solutions , a ... enforcement agencies, announced today the appointment of retired FBI ... public safety business development. Mr. Sheridan brings ... including a focus on the aviation transportation sector, to ... position, Mr. Sheridan served as the Aviation Liaison Agent ...
(Date:3/20/2017)... -- PMD Healthcare announces the release of its new ... (WMS), a remote, real-time lung health monitoring and management ... a Medical Device, Digital Health, and Chronic Care Management ... solutions that empower people to improve their healthcare and ... the first ever personal spirometer, Spiro PD, which was ...
Breaking Biology News(10 mins):
(Date:4/28/2017)... ... April 28, 2017 , ... KCAS Bioanalytical and ... 0.2 ng/mL lower limit (LLOQ) assay for nicotine and two key metabolites cotinine ... ultra-low trace nicotine assay meets additional needs of tobacco industry that need to ...
(Date:4/27/2017)... ... April 27, 2017 , ... This month ... consent (eConsent) solution that simplifies research studies, accelerates study startup, and improves participant ... Q Consent™ is the first and only IRB-integrated eConsent solution . , ...
(Date:4/27/2017)... , ... April 27, 2017 , ... ... photonics , joined other scientists, researchers, engineers, and industry professionals in visiting U.S. ... America's ability to compete in the world photonics industry. , This year, ...
(Date:4/26/2017)... SC (PRWEB) , ... April 26, 2017 , ... ... mind, has teamed up with NASA to showcase the future of deep space ... Launch System (SLS) rocket and Orion spacecraft and includes a guest appearance by ...
Breaking Biology Technology: