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

Related Content

ACC Launches Transcatheter Valve Certification
News | Heart Valve Technology | March 14, 2019
March 14, 2019 — Beginning in mid-2019, hospitals performing...
FDA Approves MitraClip for Use in Heart Failure Patients With Functional Mitral Regurgitation
Feature | Heart Valve Technology | March 14, 2019 | Jeff Zagoudis, Associate Editor
March 14, 2019 — The U.S.
Scientists Discover New Type of Immune Cells Essential for Forming Heart Valves

Microscopic images of a normal heart valve in a mouse, left, and a heart valve grown in a lab with heart-derived macrophages blocked, right. Without those macrophages, the valves are thick and deformed. Image courtesy of Developmental Cell/UCLA Broad Stem Cell Research Center.

News | Heart Valve Technology | March 06, 2019
UCLA researchers have identified for the first time the origin of an immune cell that plays a critical role in the...
Global Market for Transcatheter Treatments to Double in Next Five Years
News | Heart Valve Technology | March 01, 2019
When it comes to treatment options for a damaged heart valve, nothing is getting more attention than transcatheter...
FDA Approves IDE Study for Foldax Biopolymer Heart Valve Platform
News | Heart Valve Technology | February 18, 2019
Foldax Inc. announced the U.S. Food and Drug Administration (FDA) has granted investigative device exemption (IDE)...
Thubrikar Announces First-in-Human Implant of Optimum TAVI System
News | Heart Valve Technology | January 29, 2019
Thubrikar Aortic Valve Inc. announced the first human implant of the Optimum TAV using their transcatheter aortic valve...
Perceval Valve Offers Performance, Economic Advantages in Aortic Disease Treatment
News | Heart Valve Technology | January 29, 2019
LivaNova PLC announced the publication of three separate studies highlighting the performance of its sutureless aortic...
First Tendyne Transcatheter Mitral Valve Implanted in New York
News | Heart Valve Technology | January 28, 2019
Lenox Hill Hospital is the first hospital in New York City to successfully implant Abbott’s Tendyne transcatheter...
Overlay Init