Abbott Submits Application for Approval of XIENCE(TM) V Everolimus Eluting Coronary Stent Syste...(are metal stent. The VISION platform has...),Health

Abbott's Shonin submission for XIENCE V included data from SPIRIT III, a large-scale, randomized clinical trial of 1,002 patients conducted in the United States. The submission also included data from two non-randomized registry arms: the SPIRIT III Japan Registry of 88 patients and the SPIRIT III 4.0mm Registry of 69 patients conducted in the United States. Key results include:

* Statistical superiority for XIENCE V compared to TAXUS in the

primary endpoint of in-segment late loss at eight months in the

randomized clinical trial, where XIENCE V demonstrated a

statistically significant 50 percent reduction in late loss compared

to TAXUS (mean, 0.14 mm for XIENCE V vs. 0.28 mm for TAXUS).

In-segment late loss is a measure of vessel re-narrowing.

* Statistical non-inferiority for XIENCE V compared to TAXUS in the

co-primary endpoint of target vessel failure (TVF) at nine months in

the randomized clinical trial, where XIENCE V demonstrated an

observed 20 percent reduction in TVF compared to TAXUS (7.2 percent

for XIENCE V vs. 9.0 percent for TAXUS). TVF is a composite clinical

measure of safety and efficacy outcomes defined as cardiac death,

heart attack (myocardial infarction or MI) or target vessel

revascularization (TVR).

* An observed 43 percent reduction in major adverse cardiac events

(MACE) at nine months (4.6 percent for XIENCE V vs. 8.1 percent for

TAXUS) with XIENCE V compared to TAXUS in the randomized clinical

trial. MACE is an important clinical measure of safety and efficacy

outcomes for patients, defined as cardiac death, heart attack

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