Edwards Sapien 3 TAVR Valve Receives Expanded Approval in Canada Valve now indicated for all patients diagnosed with severe symptomatic aortic stenosis December 29, 2020 — Health Canada has approved the expanded use of the Edwards Lifesciences Sapien 3 and Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) heart valves for the transfemoral treatment of patients diagnosed with severe symptomatic aortic stenosis who are at low risk for open-heart surgery. The Sapien 3 valves are the first transcatheter aortic valve implantation (TAVI) systems to have this indication in Canada. "Now, all Canadian patients diagnosed with aortic stenosis can be considered for TAVI with the Sapien 3 valves based on individual needs rather than risk scores," said John Webb, M.D., FRCPC, director of interventional cardiology and cardiac catheterization laboratories at St. Paul's Hospital, Vancouver, and professor of cardiology at the University of British Columbia. "Previously, their only treatment option was open-heart surgery, so this approval is particularly important for patients at low risk for surgery, whose only serious health issue may be aortic stenosis and who desire a quick return home and to their everyday activities."