Press Release   -

Breakthrough Approval for Edwards' EVOQUE Valve Revolutionizes Treatment for Tricuspid Valve Disease

In a groundbreaking milestone for cardiovascular medicine, Edwards Lifesciences Corporation has achieved FDA approval for its EVOQUE tricuspid valve replacement system, marking the first transcatheter therapy sanctioned for tricuspid regurgitation (TR). This achievement represents a new era in solving the unmet needs of patients with Structural Heart Disease.

EVOQUE is a beacon of hope for patients with symptomatic severe TR, despite optimal medical treatment, thanks to the meticulous design of the system by a team of clinicians around the world. The innovative composition, including a nitinol self-expanding frame, an intra-expanding annular sealing ring and tissue leaflets made from proven bovine pericardial tissue, promises significant improvements in patient care.

The TRISCEND II Pivotal Study results presented at TCT 2023 underlined the safety and effectiveness of the system, exceeded expectations as well as demonstrated remarkable success on primary endpoints. Significant reductions in triglycerides and significant improvements in quality of life have been observed in patients, reaffirming the transformational potential of EVOQUE.

With CE Mark approval secured in October 2023, the global rollout of the EVOQUE 

system is poised to reshape treatment paradigms, offering a lifeline to millions worldwide suffering from TR. Vantage market research projects exponential market growth, with projections soaring from USD 7.77 billion in 2023 to USD 20.08 billion by 2032, reflecting an impressive compound annual growth rate (CAGR) of 11.13%.

In order to stimulate innovation and drive market growth, key industry players such as Abbott Laboratories, Medtronic plc., Edwards Lifesciences Corporation or Boston Scientific Corporation have a critical role to play. Their ongoing commitment to developing new products underlines the crucial role of innovation in defining the future of prosthetic heart valves.

As Edwards prepares to unveil the full cohort of 392 TRISCEND II crucial trial patients at TCT 2024, expectation rises for further insights into the transformative potential of the EVOQUE system. Amidst ongoing advancements in valve design and materials, the landscape of cardiovascular medicine stands poised for unprecedented progress, offering renewed hope and healing to patients worldwide.

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