Healthcare Industry News: XIENCE V
News Release - September 5, 2006
Abbott's XIENCE V(TM) Drug-Eluting Coronary Stent Superior to TAXUS(R) Stent in SPIRIT II Clinical TrialStudy Demonstrates Excellent Results for XIENCE V Stent System; Company Plans to Initiate European Launch Next Month
ABBOTT PARK, Ill. and BARCELONA, Spain, Sept. 5 (HSMN NewsFeed) -- Positive six-month results of Abbott's SPIRIT II clinical trial of the XIENCE(TM) V Everolimus Eluting Coronary Stent System were presented today at the World Congress of Cardiology conference in Barcelona, Spain. Results of the trial, which was conducted in Europe and Asia Pacific, demonstrated superiority of the XIENCE V stent system compared 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 (0.11 +/- 0.27 mm for XIENCE V vs. 0.36 +/- 0.39 mm for TAXUS, p<0.0001). Late loss is a measure of the change in the vessel diameter between the time immediately following stent placement and at six months.
Secondary endpoints of the trial also demonstrated positive results for the XIENCE V stent system, including a statistically significant reduction in percent diameter stenosis from 21 percent for TAXUS to 16 percent for XIENCE V (p<0.001). The in-stent angiographic binary restenosis rate for XIENCE V was 1.3 percent compared to 3.5 percent for the TAXUS control. Angiographic binary restenosis is the percentage of patients with occlusions 50 percent or greater at the time of six-month follow up. The six-month MACE rate for the XIENCE V stent was 2.7 percent, versus 6.5 percent for the TAXUS stent. As defined in SPIRIT II, the MACE rate includes any deaths, heart attacks or clinically driven target lesion revascularizations within the six-month period. The study also showed a stent thrombosis rate for XIENCE V of 0.5 percent (n=1) at six months compared to 1.3 percent (n=1) for that of TAXUS. The device and procedural success rates for the XIENCE V stent system were 98.8 and 99.1 percent, respectively.
"The excellent results demonstrate that in this trial, the XIENCE V stent was not only non-inferior but was also superior to the TAXUS stent, and confirm the positive results from the SPIRIT FIRST study," said Prof. Patrick W. Serruys, M.D., of the Thoraxcenter, Erasmus University Hospital, Rotterdam, principal investigator of the SPIRIT II clinical trial. "The stent system's impressive safety and efficacy data, combined with its highly deliverable platform, will make XIENCE V an attractive new drug-eluting stent for physicians and patients in Europe."
XIENCE V, which has received CE Mark approval, is currently an investigational device in the United States and Japan. The system utilizes everolimus, which has been shown to reduce tissue proliferation in the coronary vessels following stent implantation, and is based upon the highly deliverable and proven MULTI-LINK VISION® coronary stent platform.
"These positive clinical results reinforce our confidence in the XIENCE V stent system," said John M. Capek, Ph.D., president, Cardiac Therapies, Abbott Vascular. "The upcoming XIENCE V launch, combined with our robust drug- eluting stent pipeline, firmly positions Abbott Vascular as a leader in the global vascular market."
SPIRIT II is a 300-patient randomized, single-blind, prospective clinical trial evaluating XIENCE V versus the TAXUS paclitaxel-eluting coronary stent system. Results of the SPIRIT II trial will provide additional clinical data to support the launch of XIENCE V in several countries outside the United States.
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 for 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 recently enrolled its first patient, 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. SPIRIT V is a planned international clinical trial that will provide additional clinical experience with XIENCE V in approximately 3,000 patients at 100 clinical sites throughout Europe, Asia, Canada and Latin America.
About Abbott Vascular's Drug-Eluting Stent Program
Abbott Vascular's drug-eluting stent program consists of two flagship products: the XIENCE V Everolimus Eluting Coronary Stent System and the ZoMaxx(TM) Drug-Eluting Coronary Stent System. Both systems include advanced stent platforms and controlled release of a drug from the -olimus class. The ZoMaxx drug-eluting stent system features zotarolimus, a compound proprietary to Abbott, and Abbott's TriMaxx(TM) stainless steel and tantalum stent platform, which has received CE Mark approval and is available for sale in Europe and select other geographies. ZoMaxx is an investigational device in Europe and in the United States. Abbott Vascular is also developing a bioabsorbable drug-eluting stent and drug-eluting stents that release a combination of drugs.
In April 2006, Abbott acquired the vascular intervention and endovascular solutions businesses of Guidant Corporation, which had been the predominant U.S. market leader in metallic stents since the introduction of the company's first stent system in 1997.
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. For more information, visit www.abbott.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.
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