Edwards Receives Approval For SAPIEN 3 Heart Valve In Canada

IRVINE, Calif., Edwards Lifesciences Corporation, the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today 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 builds on Edwards' decades of experience in the development of tissue heart valves, and the proven benefits of the Edwards SAPIEN valves. The new 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 Dr. John Webb, 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 Edwards SAPIEN 3 valve has been commercially available in Europe since 2014, and received U.S. regulatory approval in 2015. The SAPIEN family of valves has been used in the treatment of more than 150,000 patients globally. 

Source: Edwards Lifesciences Corporation