Edwards Sapien

Edwards' SAPIEN 3 Ultra Transcatheter Heart Valve Receives FDA Approval

Posted on December 28, 2018 by Medtech[y] Staff

Edwards Lifesciences ($EW) today announced that the SAPIEN 3 Ultra system has received FDA approval for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients who are determined to be at intermediate or greater risk of open-heart surgery.

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"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," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves. "We look forward to introducing the SAPIEN 3 Ultra system to U.S. patients."

"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.

What is the SAPIEN 3 TAVR?