Sustainability report

Product safety & quality

Edwards Lifesciences’ work to maintain product safety and quality supports our aspiration of excelling as a trusted partner through distinguished quality and integrity.

Definition

Monitoring, managing and reducing negative health and safety impacts of Edwards’ products; improving overall product quality.

Our aspirations

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Excelling as a trusted partner through distinguished quality and integrity

Material topics
Highlight story

SAPIEN 3 Ultra Transcatheter Heart Valve Received FDA Approval

In 2018, our SAPIEN 3 Ultra system received U.S. Food and Drug Administration approval for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients determined to be at intermediate or greater risk of open-heart surgery. The advanced SAPIEN 3 Ultra system features enhancements on the valve and a new delivery system to address the needs of both patients and clinicians, building on our best-in-class performance of SAPIEN 3 to further advance and improve patient care. The SAPIEN 3 Ultra system utilizes Edwards' decades of engineering and experience in the development of tissue heart valves and the proven benefits of the Edwards SAPIEN valves.

"The Edwards SAPIEN 3 Ultra system provides meaningful technology improvements that help further optimize the transcatheter aortic valve replacement procedure, adding simplicity and advancing patient care," said John Webb, M.D., director of interventional cardiology and cardiac catheterization laboratories at St. Paul's Hospital, Vancouver, and professor of cardiology at the University of British Columbia.