Technology | Heart Valve Technology | January 02, 2019

Edwards' Sapien 3 Ultra Transcatheter Heart Valve Receives FDA Approval

Updated device features valve enhancements and new delivery system

Edwards' Sapien 3 Ultra Transcatheter Heart Valve Receives FDA Approval

January 2, 2019 — Edwards Lifesciences Corp. announced that the Sapien 3 Ultra system has received U.S. Food and Drug Administration (FDA) approval for transcatheter aortic valve replacement (TAVR) in severe, symptomatic aortic stenosis patients who are determined to be at intermediate or greater risk of open-heart surgery.

The Sapien 3 Ultra features enhancements on the valve over previous versions and a new “on-balloon” delivery system to address the needs of both patients and clinicians. It reportedly features an extended skirt to help avoid paravalvular leaks and a 14-French low profile sheath.

"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.

For more information: www.edwards.com

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