Abbott's XIENCE V(TM) Drug Eluting Stent Outperforms TAXUS(R) in Key Efficacy and Safety Endpoints Out to...(ary artery disease by propping open anar...),Health

Date:10/13/2008

ary artery disease by propping open a narrowed or blocked artery and releasing the drug, everolimus, in a controlled manner to prevent the artery from becoming blocked again following a stent procedure. 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.

Long-term results with XIENCE V in the SPIRIT III pivotal U.S. clinical trial demonstrated a 45 percent reduction in the risk of MACE compared to TAXUS at two years. XIENCE V demonstrated a 32 percent reduction in TVF compared to TAXUS at two years. XIENCE V also demonstrated a low rate of stent thrombosis between one and two years, defined as very late stent thrombosis, per ARC definition of definite/probable stent thrombosis (0.3 percent for XIENCE V and 1.0 percent for TAXUS). XIENCE V met its primary endpoint in the SPIRIT III clinical trial with a statistically significant 50 percent reduction in in-segment late loss (vessel renarrowing) at eight months compared to TAXUS.

The XIENCE V stent is 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 approved by the U.S. Food and Drug Administration and launched in July 2008, and was launched in Europe and other international markets in October 2006. XIENCE V is an investigational device in Japan and is currently under review by the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency.

Abbott also supplies a private-label version of XIENCE V to Boston Scientific called the PROMUS(TM) Everolimus-Eluting Coronary Stent System. PROMUS is designed and manufactured by Abbott and s
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