Edwards Sapien 3 Heart Valve Approved in Canada

July 27, 2016—Edwards Lifesciences Corporation announced that Health Canada has approved the Edwards Sapien 3 transcatheter heart valve for the treatment of patients with severe, symptomatic aortic stenosis and at high or greater risk for surgical aortic valve replacement. The Sapien 3 valve is available in 20-mm, 23-mm, 26-mm, and 29-mm sizes.

The Edwards Sapien 3 valve has been commercially available in Europe since 2014, and received US Food and Drug Administration regulatory approval in 2015.

In the company’s press release, John Webb, MD, commented, “The Sapien 3 valve has set new standards in patient outcomes and performance for heart valve replacement. Supported by large, adjudicated clinical experience demonstrating extremely low rates of mortality, stroke, and paravalvular leak at 30 days and 1 year, the Sapien 3 valve has changed the paradigm for patients in need of heart valve replacement.” Dr. Webb is Director of Interventional Cardiology and Cardiac Catheterization Laboratories at St. Paul's Hospital, Vancouver, and Professor of Cardiology at the University of British Columbia in Vancouver, British Columbia.