Edwards Lifesciences presented two‑year data for its EVOQUE transcatheter tricuspid valve replacement system at the American College of Cardiology Annual Scientific Session (ACC.26) on March 30 2026. The data come from the TRISCEND II trial, a randomized controlled study of 400 patients that has now reported sustained outcomes through 24 months.
The two‑year results confirm near‑complete elimination of tricuspid regurgitation, significant improvements in patient‑reported health status and quality of life, and a lower all‑cause mortality rate when crossover patients are accounted for. No device‑related adverse events were added beyond those seen in the first‑year analysis.
EVOQUE is the world’s first and only FDA‑ and CE‑approved transcatheter tricuspid valve replacement system, giving Edwards a first‑mover advantage in a market that is projected to grow from $552.9 million in 2024 to $957.1 million by 2032 (CAGR 7.1 %). The broader structural‑heart market is expected to expand from $16.13 billion in 2024 to $50.99 billion by 2033 (CAGR 13.5 %).
The clinical milestone supports Edwards’ strategy to expand beyond aortic valve replacement. The company’s transcatheter mitral and tricuspid therapies (TMTT) segment is projected to generate $500–530 million in revenue in 2025, a 50–60 % increase from the prior year, and the company has guided for 8–10 % sales growth in 2026 with gross margins of 78–79 %. These figures underscore the potential for the EVOQUE platform to drive future revenue and margin expansion.
"There is a significant patient population suffering from debilitating tricuspid regurgitation with very limited treatment options," said Dr. Vinod Thourani, MD, FACS, FACC, Chairman of the Department of Cardiovascular Surgery at Piedmont Heart Institute. "The crossover patients who received EVOQUE after the one‑year primary endpoint demonstrate the clear benefit of this therapy." Edwards’ corporate vice president of transcatheter mitral and tricuspid therapies, Daveen Chopra, added, "We are proud of the life‑changing benefits demonstrated with the EVOQUE system and remain focused on delivering innovative solutions for structural heart disease."
The two‑year data reinforce Edwards’ leadership position in the emerging tricuspid valve market and provide a strong evidence base that could accelerate adoption by clinicians and payers. The results also signal that the company’s broader TMTT strategy is on track to capture a larger share of the structural‑heart market as demand for less invasive therapies continues to rise.
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