Healthcare Industry News: SPIRIT II
News Release - January 11, 2007
Private-Label Version of Abbott's XIENCE(TM)V Drug-Eluting Coronary Stent System Launches in EuropeABBOTT PARK, Ill., Jan. 11 (HSMN NewsFeed) -- A private-label version of Abbott's XIENCE(TM) V Everolimus Eluting Coronary Stent System has launched in Europe, Boston Scientific Corporation announced today. The PROMUS(TM) Everolimus-Eluting Coronary Stent System is designed, studied and manufactured by Abbott and supplied to Boston Scientific as part of a distribution agreement between the two companies announced last year. Abbott secured CE mark and launched the XIENCE V stent system in Europe in October 2006, and it is currently available in most major European and Asia-Pacific markets. The company expects to launch XIENCE V in the U.S. in the first half of 2008.
"We are pleased with today's announcement, as it allows more patients to have access to the advanced next-generation drug eluting stent technology that underlies the XIENCE V system," said John M. Capek, Ph.D., president, Abbott Vascular.
Additional Clinical Trial Results in 2007
Abbott will present results from the randomized portion of the SPIRIT III pivotal trial in the first half of 2007. SPIRIT III is a large-scale pivotal clinical trial comparing the XIENCE V Everolimus Eluting Coronary Stent System to Boston Scientific's TAXUS® Paclitaxel-Eluting Coronary Stent System. The XIENCE V system is currently an investigational device in the United States and Japan.
Earlier this fall, Abbott presented 6-month results from its SPIRIT II clinical trial at the World Congress of Cardiology conference in Barcelona, Spain, that demonstrated superiority of the XIENCE V Everolimus Eluting Coronary 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.
About the XIENCE V Everolimus Eluting Coronary Stent System
The XIENCE V Everolimus Eluting Coronary Stent System is based upon the highly deliverable and proven MULTI-LINK VISION® coronary stent platform. The system utilizes everolimus, which has been shown to reduce tissue proliferation in the coronary vessels following stent implantation.
SPIRIT Family of Trials
The SPIRIT Clinical Trial Program is designed to study the safety and efficacy of the XIENCE V Stent System across five clinical trials. The SPIRIT FIRST study of the XIENCE V Stent System showed positive results through two years with no major adverse cardiac events (MACE) between one and two years in patients with de novo native coronary artery lesions.
In addition to SPIRIT II, which was conducted in Europe and Asia-Pacific, and SPIRIT III in the United States and Japan, SPIRIT IV 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 an international study that will provide additional clinical experience with the XIENCE V Everolimus Eluting Coronary Stent System at approximately 100 sites throughout Europe, Asia, Canada and Africa. The trial consists of two concurrent studies, a Diabetic Study and the Registry. The SPIRIT V Diabetic Study is a prospective, randomized single-blind study comparing the XIENCE V coronary stent system to the TAXUS® Liberte coronary stent system in the treatment of diabetic patients with coronary artery disease. The SPIRIT V Registry is a prospective, single-arm registry evaluating performance of the XIENCE V Stent System in real-world clinical settings.
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 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 www.abbott.com.
PROMUS(TM) and TAXUS® are trademarks of Boston Scientific Corporation.
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