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FDA Approves Abbott's XIENCE(TM) V Drug Eluting Stent
Date:7/2/2008

en target lesion revascularization (TLR, repeat procedures driven by lack of blood supply).

-- A 32 percent reduction in the risk of TVF compared to TAXUS (10.7 percent for XIENCE V vs. 15.4 percent for TAXUS, p-value=0.04)*.

-- Low rates 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 (0.3 percent for XIENCE V and 1.0 percent for TAXUS) and per the SPIRIT III protocol (0.2 percent for XIENCE V and 1.0 percent for TAXUS). The ARC definition of late stent thrombosis was developed to eliminate variability in the definitions across various drug eluting stent trials.

"Today's approval of XIENCE V is a reflection of Abbott's ongoing commitment to bring innovation-driven, leading-edge medical technologies to the people who need them," added Capek. "With one of the largest, most seasoned vascular sales forces in the United States and with the ability to supply more than half the worldwide market, we will begin shipping units of XIENCE V immediately to meet physician demand for this much awaited, next- generation technology."

More About XIENCE V

XIENCE V is built upon Abbott's market-leading bare metal stent, the MULTI-LINK VISION(R) Coronary Stent System. The VISION platform is designed to facilitate ease of delivery, making it easier for physicians to maneuver the stent and treat the diseased portion of the artery.

The XIENCE V drug coated stent will be available on both over-the-wire (OTW) and rapid exchange (RX) delivery systems. Rapid exchange is the most widely used type of delivery system because it provides physicians additional flexibility to work as single operators during stent procedures.

XIENCE V was launched in Europe and other international markets in October 2006. XIENCE V is an investigational device in Japan and is currently under review for approval by Japan's Ministry of Health, Lab
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SOURCE Abbott
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