Sam Brusco, Associate Editor02.02.24
Edwards Lifesciences has gained U.S. Food and Drug Administration (FDA) approval for its EVOQUE tricuspid valve replacement system to treat tricuspid regurgitation (TR). This is the first transcatheter therapy to receive this approval.
EVOQUE features a nitinol self-expanding frame, intra-annular sealing skirt, and tissue leaflets made from the company’s bovine pericardial tissue. The EVOQUE valve comes in three sizes and is indicated to improve health status in patients with symptomatic severe TR despite optimal medical therapy (OMT), for whom tricuspid valve replacement is deemed appropriate by a heart team.
Successful six-month results from the randomized controlled pivotal trial, TRISCEND II, were presented at TCT 2023 and reported favorable safety and effectiveness outcomes, showing superiority to OMT alone and meeting all primary endpoints. Key findings included significant reduction or elimination of tricuspid regurgitation and significant and sustained quality of life improvement, while demonstrating a favorable balance between risk and benefit.
“Edwards has a long history of leading innovation and pioneering new therapies to address the unmet needs of patients with structural heart disease,” said Daveen Chopra, Edwards’ corporate VP, transcatheter mitral and tricuspid therapies. “We are grateful for the strong collaboration with clinicians all over the world who contributed to the EVOQUE system now being available through FDA’s Breakthrough Pathway to provide a treatment option to the many patients in the US suffering with tricuspid valve disease.”
EVOQUE earned CE mark approval in October 2023.
EVOQUE features a nitinol self-expanding frame, intra-annular sealing skirt, and tissue leaflets made from the company’s bovine pericardial tissue. The EVOQUE valve comes in three sizes and is indicated to improve health status in patients with symptomatic severe TR despite optimal medical therapy (OMT), for whom tricuspid valve replacement is deemed appropriate by a heart team.
Successful six-month results from the randomized controlled pivotal trial, TRISCEND II, were presented at TCT 2023 and reported favorable safety and effectiveness outcomes, showing superiority to OMT alone and meeting all primary endpoints. Key findings included significant reduction or elimination of tricuspid regurgitation and significant and sustained quality of life improvement, while demonstrating a favorable balance between risk and benefit.
“Edwards has a long history of leading innovation and pioneering new therapies to address the unmet needs of patients with structural heart disease,” said Daveen Chopra, Edwards’ corporate VP, transcatheter mitral and tricuspid therapies. “We are grateful for the strong collaboration with clinicians all over the world who contributed to the EVOQUE system now being available through FDA’s Breakthrough Pathway to provide a treatment option to the many patients in the US suffering with tricuspid valve disease.”
EVOQUE earned CE mark approval in October 2023.