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Abbott's XIENCE(TM) V Everolimus Eluting Coronary Stent Shows Continued Superiority to TAXUS Stent in Reducing Major Adverse Cardiac Events in SPIRIT III Clinical Trial
Date:10/22/2007

trial was not designed to analyze statistical differences in any of the sub-groups, including diabetic patients.

"The results from XIENCE V represent an important advancement for patients with coronary artery disease," said John M. Capek, Ph.D., executive vice president, Medical Devices, Abbott. "As a next generation drug eluting stent, XIENCE V continues to demonstrate longer-term safety and consistently superior efficacy results across the SPIRIT trials with the potential to raise the bar for all DES."

About XIENCE V

The XIENCE V 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.

XIENCE V was launched in Europe and Asia Pacific in 2006. XIENCE V is currently an investigational device in the United States and Japan. Results from the SPIRIT III trial are intended to support U.S. Food and Drug Administration (FDA) approval of the XIENCE V Stent System and Ministry of Health and Welfare approval in Japan. Abbott anticipates receiving XIENCE V U.S. FDA approval in the first half of 2008.

Abbott supplies a private-label version of XIENCE V, called the PROMUS(TM) Everolimus-Eluting Coronary Stent System, to Boston Scientific as part of a distribution agreement established between the two companies last year.

About the SPIRIT Family of Trials

SPIRIT FIRST was a first-in-man study comparing the XIENCE V Everolimus Eluting Coronary Stent System with the MULTI-LINK VISION metallic stent system. SPIRIT FIRST demonstrated positive results with one MACE event at one year and no additional MACE events out to three years. In addition, the number of late stent thromboses in the XIENCE V arm of the SPIRIT FIRST trial was zero out to three years of clinical follow-up.

SPIRIT II is a 300-patient randomized, single-blind, prospective clinical trial evaluating XIE
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SOURCE Abbott
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