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."
The approval is based on data from the landmark PARTNER 3 Trial, an independently evaluated, randomized clinical trial, which reported a 46% lower event rate for death from any cause, stroke, or rehospitalization at 1 year after TAVI compared to open heart surgery. Patients treated with the Sapien 3 valve experienced 1% rates of death or disabling stroke at 1 year, a short length of stay and 96% discharged to home or self-care. Patients also reported significant improvements to health status and quality of life as early as 1 month after the procedure. Importantly, these findings were sustained out to 12 months post-procedure. Severe aortic stenosis is a debilitating disease that often goes undiagnosed and is undertreated.
The Sapien valves are the most widely studied transcatheter valves, with more than 30,000 patients treated in clinical trials and registries in over 65 countries around the world. Since the first commercial approval of the Sapien transcatheter valve in Europe in 2007, the Sapien family of valves have treated hundreds of thousands of patients worldwide. The Sapien 3 valves, previously approved in Canada for the treatment of both high-risk patients and intermediate-risk patients, build on Edwards' decades of experience in the development of tissue heart valves, and the proven benefits of the Edwards Sapien valves.
1. M.J. Mack, M.B. Leon, V.H. et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients, The New England Journal of Medicine, 2019. N Engl J Med 2019; 380:1695-1705. DOI: 10.1056/NEJMoa1814052.