Healthcare Industry News: drug-eluting stent
News Release - May 15, 2006
Abbott Announces First Patients Enrolled in ZOMAXX(TM) EUROPE Clinical TrialSingle-arm Study to Treat Patients With Multi-vessel Coronary Artery Disease
ABBOTT PARK, Ill., May 15 (HSMN NewsFeed) -- Abbott today announced that the first patients were enrolled in its ZOMAXX EUROPE clinical trial, and all were treated with the ZoMaxx(TM) Drug-Eluting Coronary Stent System for their coronary artery disease.
The ZOMAXX EUROPE study is a single-arm trial that will evaluate the safety and performance of the ZoMaxx zotarolimus-eluting stent in patients with single- or two-vessel coronary artery disease, representing an important step toward broadening the complexity of patients treated with ZoMaxx. The study will include approximately 900 patients at up to 60 sites throughout Europe with a primary endpoint of target lesion revascularization (TLR) at nine months.
Karl E. Hauptmann, M.D., Head of Internal Medicine in the department of Cardiology, at Krankenhaus der Barmherzigen Bruder (Hospital of the Merciful Brother) in Trier, Germany, performed the first procedures.
"We are pleased to take part in this important study of the safety and performance of the ZoMaxx zotarolimus-eluting coronary stent," said Franz-Josef Neumann, M.D., of Herz-Zentrum Bad Krozingen hospital in Baden-Wurttemberg Germany, principal investigator of ZOMAXX EUROPE and Honorary Professor at the University of Freiburg. "Abbott's drug-eluting stent has unique characteristics, and we look forward to studying the ZoMaxx system in patients with coronary artery disease, including those suffering from multi-vessel disease."
"The initiation of ZOMAXX EUROPE is the latest step forward in the development of the ZoMaxx drug-eluting stent to treat patients suffering from coronary artery disease," said Robert B. Hance, president, Vascular Solutions, Abbott Vascular. "Combined with the recent announcement of encouraging results of the ZOMAXX IVUS trial, this development exemplifies Abbott's continued commitment to bring the ZoMaxx stent to clinicians around the world."
Abbott plans to seek approval to market ZoMaxx in Europe in 2006.
About The ZoMaxx Drug - Eluting Coronary Stent
The ZoMaxx Drug-Eluting Coronary Stent System features proprietary application of a biologically inert coating called Pharmacoat (phosphorylcholine, or PC), intended to enable steady drug elution over time, and proprietary application of Abbott's patent-protected immunosuppressant drug, zotarolimus, which has been studied for the reduction of vessel re-narrowing. Zotarolimus is the only drug designed exclusively for use on drug-eluting stents. The system's TriMaxx(TM) stent platform is made of stainless steel and tantalum to enable optimal visibility under X-ray, with extremely thin struts and an ultra-low crossing profile to facilitate ease of stent placement.
Phosphorylcholine is licensed to Abbott from Biocompatibles International plc.
About Abbott Vascular
Abbott Vascular, a division of Abbott, is transforming the treatment of vascular disease, combining the latest medical device innovations with world-class pharmaceuticals to advance medicine and improve patient care. Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products that are recognized internationally for their safety, effectiveness and ease of use in treating patients with vascular disease. Abbott Vascular is headquartered in Redwood City, Calif. For more information, visit http://www.abbottvascular.com .
Abbott (NYSE: ABT ) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com .
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