Abbott gets Health Canada nod to market Xience V drug eluting stent
Abbott announced 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, FRCPC, FACC, interventional cardiologist and associate professor of research, Centre Hospitalier de 'Université de Montréal. "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. Furthermore, 54 percent of all cardiovascular deaths are due to CAD, whereby plaque build-up narrows the arteries and reduces blood flow to the heart, which can lead to chest pain or a heart attack.
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."