Edwards’ EVOQUE Valve Replacement System First Transcatheter Therapy to Earn FDA Approval for Tricuspid Valve

Edwards Lifesciences Corporation (NYSE: EW) today announced the company’s EVOQUE tricuspid valve replacement system is the first transcatheter therapy to receive U.S. Food and Drug Administration (FDA) approval for the treatment of tricuspid regurgitation (TR). The EVOQUE system is indicated for the improvement of 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.

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(Photo: Edwards Lifesciences)

“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 vice president, 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.”

The EVOQUE system is comprised of a nitinol self-expanding frame, intra-annular sealing skirt and tissue leaflets made from the company’s proven bovine pericardial tissue. The EVOQUE valve will be available in three sizes, all delivered through the same low-profile transfemoral 28F system.

“Patients suffering with tricuspid regurgitation endure life-impairing symptoms and, until today, had no approved transcatheter treatment options,” said Susheel Kodali, MD, director, Structural Heart and Valve Center at Columbia University Irving Medical Center/New York-Presbyterian Hospital and TRISCEND II Study Principal Investigator. “The EVOQUE system is able to replace the native tricuspid valve, virtually eliminating tricuspid regurgitation in a wide range of patients. We see significant improvements in patients’ symptoms and quality-of-life, including not feeling short of breath and being able to care for themselves, which ranked highest on a patient preference survey conducted at baseline with TRISCEND II pivotal trial patients.”