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Abbott Submits Application for Approval of XIENCE(TM) V Everolimus Eluting Coronary Stent System in Japan
Date:6/2/2008

ardial infarction or MI), or ischemia-driven target lesion

revascularization (TLR driven by lack of blood supply).

* Positive results confirming the efficacy and safety of XIENCE V from

the SPIRIT III Japan Registry. The Japan Registry met its primary

endpoint of in-segment late loss at eight months. A full analysis of

the SPIRIT III Japan Registry will be presented later this year.

"The strong, positive data indicate that XIENCE V is a true next-generation drug eluting stent that combines advanced technology with outstanding clinical benefits in the treatment of coronary artery disease," said Shigeru Saito, M.D., F.A.C.C., F.S.C.A.I., F.J.C.C., director, Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, and principal investigator for the SPIRIT III Japan Registry.

Additional Long-term Data on XIENCE V

In May 2008, Abbott presented long-term data from the SPIRIT III randomized clinical trial demonstrating that XIENCE V continues to deliver clinically superior benefits for patients compared to TAXUS. Consistent with earlier results, XIENCE V demonstrated a 45 percent reduction in the risk of major adverse cardiac events (MACE) and a 32 percent reduction in the risk of target vessel failure (TVF) at two years compared to TAXUS.

XIENCE V also demonstrated a low rate of stent thrombosis between one and two years, defined as very late stent thrombosis, per Academic Research Consortium (ARC) definition of definite/probable stent thrombosis and per the SPIRIT III protocol.

About the SPIRIT III Clinical Trial

SPIRIT III is a prospective, multi-center, randomized, single-blind, controlled clinical trial comparing XIENCE V to TAXUS in 1,002 patients (669 XIENCE V patients, 333 TAXUS patients) in the United States with either one or two de novo native coronary artery lesions. The SPIRIT III Japan Registry is a non-randomized, prospective, multi-center cli
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SOURCE Abbott
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