Health Canada Approves Abbott's XIENCE V(R) Drug Elu...(he SPIRIT II trial MACE is defined as a ...),Health

In addition, there was no occurrence of stent thrombosis between two and three years with XIENCE V in the SPIRIT II trial, and a low rate of stent thrombosis from zero to three years, per ARC definition of definite/probable stent thrombosis (0.9 percent for XIENCE V vs. 2.8 percent for TAXUS)*.

In May 2009, Abbott presented one-year data from the SPIRIT V (five) international, single-arm study, which evaluated XIENCE V in 2,663 patients - including more than 200 patients enrolled at seven sites across Canada. XIENCE V demonstrated low rates of repeat procedure (target lesion revascularization or TLR), stent thrombosis and MACE in a diverse, "real world" population of patients and lesion types, including patients with diabetes, patients with multi-vessel disease and patients with highly complex lesions. In the SPIRIT V study, XIENCE V demonstrated a very low 1.8 percent rate of TLR, a 0.7 percent rate of definite/probable stent thrombosis and a 5.1 percent rate of MACE at one year. For the SPIRIT V trial, MACE is defined as a composite of cardiac death, heart attack (myocardial infarction not clearly attributed to a non-target vessel), or TLR.

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.

Abbott's market-leading
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