MISSISSAUGA, Ontario,
Dec. 18, 2020 /CNW/ -- Edwards
Lifesciences Corporation today 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 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. "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 1.0%
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-procedurei. 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.
About Edwards Lifesciences
Edwards Lifesciences is
the global leader of patient-focused innovations for structural
heart disease and critical care monitoring. We are driven by a
passion for patients, dedicated to improving and enhancing lives
through partnerships with clinicians and stakeholders across the
global healthcare landscape.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards
SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, PARTNER, PARTNER
3, SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards
Lifesciences Corporation. All other trademarks are the property of
their respective owners. This statement is made on behalf of
Edwards Lifesciences Corporation and its subsidiaries.
i 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
SOURCE Edwards Lifesciences Corporation