Edwards Lifesciences welcomed the updated ESC/EACTS guidelines for valvular heart disease on August 29, 2025, which establish a simplified care pathway for all severe aortic stenosis (AS) patients, including those without symptoms. These guidelines represent a meaningful shift from the prior practice of 'watchful waiting' by recommending intervention for asymptomatic patients regardless of heart function.
The updated guidelines also reduced the age threshold for Transcatheter Aortic Valve Replacement (TAVR) to 70, reflecting strong confidence in TAVR’s long-term safety, efficacy, and durability. Edwards is currently the only company with an approved TAVR indication in both the US and Europe for asymptomatic severe AS, positioning its SAPIEN 3 platform favorably.
Furthermore, new data on the EVOQUE transcatheter tricuspid valve replacement (TTVR) therapy from the TRISCEND II study, presented at ESC Congress 2025, showed a significant reduction in heart failure hospitalizations at 18 months. These guideline changes and clinical evidence are expected to improve clinical outcomes, expand patient access, and benefit the healthcare system, aligning with Edwards' strategic goals.
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