Edwards Lifesciences has announced that Health Canada has approved the expanded use of the Edwards Sapien 3 and Sapien 3 Ultra transcatheter 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, director of interventional cardiology and cardiac catheterization laboratories at St. Paul’s Hospital and professor of cardiology at the University of British Columbia, Vancouver, Canada. “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 PARTNER 3 Trial, an independently evaluated, randomised clinical trial, which reported a 46% lower event rate for death from any cause, stroke, or rehospitalisation at one year after TAVI compared to open heart surgery. Patients treated with the Sapien 3 valve experienced 1% rates of death or disabling stroke at one year, a short length of stay and 96% discharged to home or self-care.