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Abbott Announces Approval in China for Next-Generation XIENCE V(R) Drug Eluting Stent
Date:9/14/2009

serious health issue in China, with more patients being diagnosed each day, so it is critical to have access to advanced technology, such as XIENCE V, that can help improve patient outcomes," said Run Lin Gao, M.D., vice president, Chinese Medical Doctor Association.

"Clinical trial results show that XIENCE V has a strong safety and efficacy profile, with impressively low rates of major adverse cardiac events and target vessel failure. Based on the strength of the data supporting it, XIENCE V is a welcome addition to the heart disease treatment options available to physicians in China," said Yong Huo, M.D., president-elect, Chinese Society of Cardiology.

SPIRIT Body of Data for XIENCE V

The clinical program for XIENCE V includes outstanding long-term results from the SPIRIT family of trials, including data from more than 60 patients based in China. In October 2008 at the Transcatheter Cardiovascular Therapeutics annual meeting, Abbott presented two-year results from a meta-analysis of the SPIRIT II and SPIRIT III* randomized clinical trials, which included 1,302 patients from the United States, Europe and the Asia-Pacific region. In this meta-analysis, XIENCE V demonstrated a 45 percent reduction in the risk of major adverse cardiac events (MACE) compared to TAXUS at two years (7.1 percent for XIENCE V vs. 12.3 percent for TAXUS, p-value=0.001)** . MACE is an important composite clinical measure of safety and efficacy outcomes for patients, defined as cardiac death, heart attack (myocardial infarction or MI), or ischemia-driven target lesion revascularization (ID-TLR driven by lack of blood supply).

XIENCE V also demonstrated significantly lower clinical events rates than TAXUS in the key efficacy (ID-TLR) and safety (cardiac death or heart attack) components of MACE at two years in the SPIRIT II and SPIRIT III meta-analysis. XIENCE V demonstrated a 41 percent reduction in the risk of ID-TL
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SOURCE Abbott
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