Edwards Sapien 3 TAVR System Receives Expanded Approval in Canada for Low-Risk Patients

December 18, 2020—Edwards Lifesciences Corporation announced that Health Canada has approved the expanded use of the Edwards Sapien 3 and Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) systems 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 were previously approved in Canada for the treatment of both high-risk patients and intermediate-risk patients.

“Now, all Canadian patients diagnosed with aortic stenosis can be considered for TAVR with the Sapien 3 valves based on individual needs rather than risk scores,” commented John Webb, MD, FACC, in the company’s announcement. “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.” 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, Canada.

According to Edwards, the approval is based on data from the landmark PARTNER 3 trial, an independently evaluated randomized clinical trial that reported a 46% lower event rate for death from any cause, stroke, or rehospitalization at 1 year after TAVR compared to surgery.

Patients treated with the Sapien 3 valve experienced 1% rates of death or disabling stroke at 1 year and a short length of stay, and 96% were 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. These findings were sustained out to 12 months postprocedure.

In 2019, the 1-year findings from the PARTNER 3 trial were presented by Martin B. Leon, MD, at the American College of Cardiology’s 68th Annual Scientific Session held in New Orleans, Louisiana, and published by Michael J. Mack, MD, et al in The New England Journal of Medicine (2019;380:1695-1705).