FDA Grants Approval to Edwards’ EVOQUE Valve Replacement System, Marking a Milestone as the First Transcatheter Therapy for Tricuspid Valve

Edwards Lifesciences Corporation (NYSE: EW) has announced the FDA approval of its EVOQUE tricuspid valve replacement system, marking a groundbreaking achievement as the first transcatheter therapy authorized for treating tricuspid regurgitation (TR) in the United States. The EVOQUE system is designed to enhance the health status of patients with symptomatic severe TR despite optimal medical therapy (OMT), for whom tricuspid valve replacement is considered suitable by a heart team.

Daveen Chopra, Edwards’ corporate vice president of transcatheter mitral and tricuspid therapies, expressed the company’s commitment to innovation in addressing the unmet needs of patients with structural heart disease. He acknowledged the collaboration with clinicians worldwide, which contributed to the availability of the EVOQUE system through the FDA’s Breakthrough Pathway, providing a vital treatment option for patients grappling with tricuspid valve disease in the United States.

Comprising a nitinol self-expanding frame, intra-annular sealing skirt, and tissue leaflets made from Edwards’ proven bovine pericardial tissue, the EVOQUE valve will be offered in three sizes, all delivered through the same low-profile transfemoral 28F system.

Dr. Susheel Kodali, director of the Structural Heart and Valve Center at Columbia University Irving Medical Center/New York-Presbyterian Hospital and Principal Investigator for the TRISCEND II Study, emphasized the significant impact of the EVOQUE system on patients suffering from tricuspid regurgitation. The system, capable of replacing the native tricuspid valve, demonstrated substantial improvements in symptoms and quality of life, as evidenced by the TRISCEND II pivotal trial results.

The six-month results from the TRISCEND II trial, presented at TCT 2023, highlighted favorable safety and effectiveness outcomes, showcasing superiority over OMT alone and meeting primary endpoints. The trial demonstrated a marked reduction or elimination of tricuspid regurgitation and sustained quality of life improvement, with a favorable balance between risk and benefit.

Edwards anticipates presenting the complete cohort of 392 TRISCEND II pivotal trial patients at TCT 2024. Having received CE Mark approval in October 2023, the EVOQUE system stands as the world’s first transcatheter valve replacement therapy authorized to treat TR.

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