IRVINE, Calif. - Edwards Lifesciences Corporation (NYSE: NYSE:EW) today gained the U.S. Food and Drug Administration (FDA) approval for its EVOQUE tricuspid valve replacement system, a first-of-its-kind transcatheter therapy for treating tricuspid regurgitation (TR). The EVOQUE system is designed to improve health outcomes in patients with severe symptomatic TR who have not responded adequately to optimal medical therapy and are considered appropriate candidates for tricuspid valve replacement by a heart team.
The EVOQUE valve consists of a nitinol self-expanding frame, an intra-annular sealing skirt, and tissue leaflets made from bovine pericardium, a material used in other Edwards Lifesciences heart valves. Available in three sizes, the valve is delivered via a transfemoral 28F system.
This FDA approval follows the successful six-month results from the TRISCEND II pivotal trial presented at TCT 2023. The trial demonstrated the system's superiority over optimal medical therapy alone, meeting all primary endpoints, including a significant reduction or elimination of TR and sustained quality-of-life improvements. The one-year follow-up of 318 patients showed favorable trends in the device group compared to the control group across various primary composite endpoints.
Daveen Chopra, the company’s corporate vice president said, "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."
Dr. Susheel Kodali, the study's principal investigator, highlighted the system's ability to alleviate life-impairing symptoms and improve patient self-care.
The EVOQUE system also received CE Mark approval in October 2023, marking it as the world's first transcatheter valve replacement therapy approved to treat TR. "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."
The information in this article is based on the press release statement from Edwards Lifesciences Corporation.
InvestingPro Insights
Amidst the groundbreaking FDA approval of Edwards Lifesciences' EVOQUE tricuspid valve replacement system, the company's financial health and market performance provide additional context for investors. Edwards Lifesciences (NYSE: EW) boasts a robust market capitalization of $47.74 billion, underlining its significant presence in the medical technology sector. The company's dedication to innovation is not only reflected in its product development but also in its financial strategy, as evidenced by management's aggressive share buyback policy—an InvestingPro Tip that signals confidence in the company's value.
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