New Drug Eluting Stent Offers Outstanding Combination of Deliverability, Safety and Efficacy
ABBOTT PARK, Ill., Aug. 24 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) announced today that it has received approval from Health Canada for the XIENCE V(R) 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(R) 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'Universite de Montreal. "With strong, long-term data supporting it, XIENCE V is a welcome addition for treating patients with coronary artery disease."
Cardiovascular disease is the leading cause of death in Canada.(1) Furthermore, 54 percent of all cardiovascular deaths are due to CAD, whereby plaque buildup narrows the arteries and reduces blood flow to the heart, which can lead to chest pain or a heart attack.(1)
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. This is why physicians have embraced XIENCE V, making it the market-leading drug eluting stent around the world," said Robert Hance, senior vice president, vascular, Abbott. "We look forward to launching XIENCE V immediately in Canada to meet physician demand for this much-awaited drug eluting stent technology."
Outstanding Clinical Evidence for XIENCE V
The clinical program for XIENCE V studied patients in the United States, Canada, Europe, South Africa and Asia-Pacific, and demonstrated excellent 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.
