Sapien 3 Ultra receives FDA approval

Sapien 3

It has been announced that the Sapien 3 Ultra system (Edwards Lifesciences) has received US FDA approval for transcatheter aortic valve implantation (TAVI) in severe, symptomatic aortic stenosis patients who are 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,” says Larry L Wood, Edwards’ corporate vice president, transcatheter heart valves. “We look forward to introducing the Sapien 3 Ultra system to US patients.”

The Sapien 3 Ultra system builds on 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 optimise the transcatheter aortic valve replacement procedure, adding simplicity and advancing patient care,” said John Webb, director of interventional cardiology and cardiac catheterisation laboratories at St. Paul’s Hospital and professor of cardiology at the University of British Columbia, Vancouver, Canada. Webb is a consultant to Edwards Lifesciences.


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