The Evoque tricuspid valve replacement system by Edwards Lifesciences has been approved by the FDA, marking the first transcatheter treatment for tricuspid regurgitation (TR) in the U.S. This system is intended for patients with symptomatic severe TR despite optimal medical therapy and for whom tricuspid valve replacement is appropriate.
The Evoque system, made up of a nitinol self-expanding frame, intra-annular sealing skirt, and tissue leaflets, will be available in three sizes, all delivered through the same low-profile transfemoral 28F system. The approval was granted based on the favorable six-month results from the TRISCEND II pivotal trial, which demonstrated significant reduction or elimination of tricuspid regurgitation, along with improvements in quality of life.
This approval is a significant step forward for patients suffering from tricuspid valve disease and offers a new treatment option in the U.S.