Company Expects to Achieve a Leadership Position in Drug-Eluting Stent Market with XIENCE V
ABBOTT PARK, Ill., Oct. 3 / - Abbott (NYSE:ABT) today announced that it has begun the international launch of the XIENCE(TM) V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease earlier than the company's original projections. The XIENCE V stent system will be launched in the majority of European countries immediately. The company also announced that it will focus its commercial, manufacturing and clinical resources on the successful launch of XIENCE V and will not pursue commercialization of its ZoMaxx(TM) Drug-Eluting Coronary Stent System.
"The positive, differentiating clinical results that XIENCE V demonstrated in SPIRIT II, combined with positive physician feedback about XIENCE V, indicates that XIENCE has significant potential to meet critical next- generation drug-eluting stent needs for physicians and patients," said John M. Capek, Ph.D., president, Cardiac Therapies, Abbott Vascular.
Positive clinical results for XIENCE V from the SPIRIT II trial announced at the World Congress of Cardiology on September 5, 2006, demonstrated that XIENCE V showed statistically significant superiority to the TAXUS® paclitaxel-eluting coronary stent system with respect to the study's primary endpoint, which was angiographic in-stent late loss at six months. Twelve- month results from SPIRIT II and nine-month results from SPIRIT III will be presented in the first half of 2007. The XIENCE V stent system has received CE Mark and is currently an investigational device in the United States and Japan.
"The XIENCE V drug-eluting stent system offers an excellent combination of technologies to deliver an advanced treatment for patients with coronary artery disease," said Eulogio Garcia Fernandez, M.D., Gregorio Maranon University General Hospital, Madrid, Spain. "Its highly deliverable MULTI- LINK VISION® coronary stent platform, the biocompatible coating and the anti-proliferative, anti-inflammatory, everolimus, plus encouraging clinical results, suggest that XIENCE V will become a preferred treatment of choice for coronary artery disease in Europe."
Focus on XIENCE V
After analyzing the clinical data from both the XIENCE V and ZoMaxx programs, Abbott has determined that it will not pursue commercialization of ZoMaxx, and will instead focus its commercial, manufacturing and clinical resources on XIENCE V. Nine-month clinical data from ZOMAXX I, Abbott's international ZoMaxx trial, will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington D.C. on October 23, 2006.
"We have conducted a thorough analysis of all available clinical data for both XIENCE V and ZoMaxx, and have concluded that XIENCE V is a significantly better product," said Richard A. Gonzalez, president and chief operating officer, Abbott. "Following encouraging physician feedback from our pre- launch evaluation program in Europe, and given the positive XIENCE V data, we remain confident in our ability to achieve a leadership position in the drug- eluting stent market with the XIENCE V platform."
Abbott recently announced that it is expanding its drug-eluting stent manufacturing capacity in Ireland to prepare for future launches in the U.S. and Japan.
"Abbott is pleased to offer XIENCE V as a new treatment option to European physicians for patients with coronary artery disease, which remains a leading cause of death around the world," Capek said. "As a leader in vascular care, Abbott will continue to deliver on its commitment to provide innovative technologies to advance the treatment of vascular disease."
SPIRIT V Clinical Trial
Abbott also announced it will initiate SPIRIT V, an international study that will provide additional clinical experience with the XIENCE V stent system in approximately 3,000 patients at approximately 100 sites throughout Europe, Asia, Canada and Latin America. The trial consists of two concurrent studies, the Diabetic Study and a Registry. The SPIRIT V Diabetic Study is a prospective, randomized, single-blind study comparing the XIENCE V stent system to the TAXUS® Liberte(TM) stent system in the treatment of diabetic patients with coronary artery lesions who will fulfill the eligibility criteria. The SPIRIT V Registry is a prospective, single-arm, registry evaluating performance of the XIENCE V stent system in real-world clinical settings.
About the SPIRIT Family of Trials
The SPIRIT FIRST study of the XIENCE V Stent System showed positive results through two years with no MACE events between one and two years in patients with de novo native coronary artery lesions. SPIRIT II and SPIRIT III are large-scale pivotal clinical trials comparing XIENCE V to the TAXUS paclitaxel eluting coronary stent system. SPIRIT IV, which already has more than 100 patients enrolled, will evaluate the safety and efficacy of the XIENCE V Stent System for the treatment of coronary artery disease in a more complex patient population in the United States.
About Abbott Vascular
Abbott Vascular, a division of Abbott, is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Headquartered in Northern California, 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 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.
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