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Abbott Announces Health Canada Approval For XIENCE V Drug Eluting Stent

Abbott announced that it has received approval from Health Canada for the XIENCE V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease (CAD). XIENCE V is the only drug eluting stent to have demonstrated superiority over the TAXUS Paclitaxel-Eluting Coronary Stent System (TAXUS) in the primary endpoints of two randomized, pivotal (phase III) clinical trials. Abbott will launch XIENCE V in Canada immediately.

XIENCE V is an important next-generation treatment option combining impressive deliverability with demonstrated efficacy and safety, said Guy Leclerc, M.D., FRCPC, FACC, interventional cardiologist and associate professor of research, Centre Hospitalier de l’Université de Montréal.With strong, long-term data supporting it, XIENCE V is a welcome addition for treating patients with coronary artery disease.

The XIENCE V drug coated stent is used to treat CAD by propping open a narrowed or blocked artery and releasing the drug, everolimus, in a controlled manner over time to help prevent the artery from becoming blocked again following the stent procedure.

XIENCE V represents a major advancement in the treatment of heart disease, based upon its ease of use and consistently strong performance across all clinical trials, said Robert Hance, senior vice president, vascular, Abbott. We look forward to launching XIENCE V immediately in Canada to meet physician demand for this drug eluting stent technology.

The clinical program for XIENCE V studied patients in the United States, Canada, Europe, South Africa and Asia-Pacific, and demonstrated positive long-term results and data on real-world patients from the SPIRIT family of trials.

In long-term data from the SPIRIT III trial of 1,002 patients, XIENCE V continued to demonstrate positive clinical benefits for patients out to two years. XIENCE V demonstrated a 45 percent reduction in the risk of major adverse cardiac events (MACE) compared to TAXUS (7.3 percent for XIENCE V vs. 12.8 percent for TAXUS) at two years. MACE is an important composite clinical measure of safety and efficacy outcomes for patients, and is defined as a composite of cardiac death, heart attack (myocardial infarction or MI), or ischemia-driven target lesion revascularization (ID-TLR driven by lack of blood supply) for the SPIRIT III trial. XIENCE V also demonstrated a low rate of stent thrombosis between one and two years per Academic Research Consortium (ARC) definition of definite/probable stent thrombosis (0.3 percent for XIENCE V vs. 1.0 percent for TAXUS). The ARC definitions of stent thrombosis were developed to eliminate variability in the definitions across various drug eluting stent trials.