Edwards Lifesciences has received approval from the US Food and Drug Administration (FDA) for its EVOQUE tricuspid valve replacement system, a transcatheter therapy, for treating TR.
The system has been designed for patients with symptomatic severe TR who have not responded to optimal medical therapy and for whom valve replacement is considered appropriate by a heart team.
It features a nitinol self-expanding frame, an intra-annular sealing skirt, and tissue leaflets crafted from Edwards Lifesciences’s bovine pericardial tissue.
