Trilogy Heart Valve System
Commercial- Indications
- Aortic regurgitation, Aortic stenosis
Company intelligence / Profile preview
The pivotal ALIGN‑AR trial of the Trilogy Heart Valve System met primary safety and efficacy endpoints at both the one-year and two-year marks. Significant residual regurgitation was eliminated in all patients, with strong safety outcomes including low all-cause mortality at one year. The device has CE mark approval in Europe for both AR and AS, with U.S. FDA approval anticipated by late 2025.
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