Health Canada approves Abbott’s Xience V


Abbott announced on 24 August that it has received approval from Health Canada for the Xience V everolimus-eluting coronary stent system for the treatment of coronary artery disease. According to Abbott, Xience V is the only drug-eluting stent to have demonstrated superiority over the Taxus paclitaxel-eluting coronary stent system (Boston Scientific) in the primary endpoints of two randomised, 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, 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.”

The clinical program for Xience V studied patients in the US, 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% reduction in the risk of major adverse cardiac events compared to Taxus (7.3% for Xience V vs. 12.8% for Taxus) at two years. Major adverse cardiac event is defined as a composite of cardiac death, myocardial infarction, or ischaemia-driven target lesion revascularisation for the SPIRIT III trial. Xience V also demonstrated a low rate of stent thrombosis between one and two years per Academic Research Consortium definition of definite/probable stent thrombosis (0.3% for Xience V vs. 1% for Taxus).