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Abbott Receives CE Mark for Smaller-Size XIENCE(TM) V Drug Eluting Stent
Date:3/10/2008

he SPIRIT family of trials, XIENCE V demonstrated:
-- Superiority for XIENCE V compared to TAXUS(R) paclitaxel eluting

coronary stent system in the primary endpoint of angiographic In-Stent

Late Loss in the SPIRIT II clinical trial at six months, with a

statistically significant 69 percent reduction for XIENCE V. In-stent

late loss is a measure of vessel renarrowing within the margins of the

stent.

-- Superiority for XIENCE V compared to the TAXUS in the primary endpoint

of angiographic In-Segment Late Loss at eight months in the SPIRIT III

clinical trial, with a statistically significant 50 percent reduction

for XIENCE V. In-segment late loss is a measure of vessel renarrowing.

-- An observed 43 percent reduction in major adverse cardiac events (MACE)

compared to TAXUS at one year in SPIRIT III. MACE is an important

clinical measure of safety and efficacy outcomes for patients, and is

defined as cardiac death, heart attack (myocardial infarction or MI),

or ischemia-driven target lesion revascularization (TLR associated with

symptoms or documented lack of blood supply).

-- Non-inferiority to TAXUS with an observed 23 percent reduction in

Target Vessel Failure (TVF) for XIENCE V compared to TAXUS in the

SPIRIT III clinical trial at one year. Target Vessel Failure is a

measure of re-treatment anywhere within the target vessel and includes

cardiac death or heart attack.

Additionally, data from an independent pooled subset analysis of SPIRIT II and SPIRIT III at one year showed:
-- A statistically significant 59 percent reduction in angiographic

In-Stent Late Loss for XIENCE V compared to TAXUS for lesions in a

reference vessel diameter less than 2.5 mm.

-- An observed 61 percent reduction in angiographic In-Segment Late Loss

for XIENCE V co
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SOURCE Abbott
Copyright©2008 PR Newswire.
All rights reserved

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