July 27, 2016 — Edwards Lifesciences Corp. announced that Health Canada has approved the Edwards Sapien 3 transcatheter heart valve for the treatment of patients living with severe, symptomatic aortic stenosis and at high or greater risk for surgical aortic valve replacement.
The Sapien 3 valve is available in sizes 20mm, 23mm, 26mm and 29mm.
"The Sapien 3 valve has set new standards in patient outcomes and performance for heart valve replacement," said John Webb, M.D., director of interventional cardiology and cardiac catheterization laboratories at St. Paul's Hospital, Vancouver, and professor of cardiology at the University of British Columbia. "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."
The device has been commercially available in Europe since 2014, and received U.S. regulatory approval in 2015.
For more information: www.edwards.com