Edwards Lifesciences (NYSE: EW) welcomes the updated ESC/EACTS guidelines for valvular heart disease, which establish a simplified care pathway for all severe aortic stenosis (AS) patients, regardless of symptoms.
The guidelines enable a proactive approach to disease management and underscore that intervention should be considered for asymptomatic patients, regardless of heart function, which is a meaningful step forward from the prior practice of “watchful waiting.” The age threshold for TAVR was reduced to 70, reflecting the strong confidence in TAVR’s long-term safety, efficacy and durability.
Edwards is currently the only company with an approved TAVR indication in the US and Europe for asymptomatic severe AS. The EARLY TAVR trial played a key role in informing these guidelines updates and supporting the recent CE Mark indication for the Edwards SAPIEN 3 platform. SAPIEN 3 Ultra RESILIA offers an evidence-based option addressing durability and lifetime management. Since its introduction more than two decades ago, SAPIEN has become the most studied valve platform, with more than 1 million patients treated.
The guidelines also strengthen recommendations for transcatheter mitral and tricuspid repair and replacement therapies. In addition, Edwards presented new data today at the ESC Congress 2025 on the EVOQUE transcatheter tricuspid valve replacement (TTVR) therapy in the TRISCEND II study. The data showed that at 18 months EVOQUE significantly reduced the hard endpoint of heart failure hospitalizations with the most severe tricuspid regurgitation patients. These data also confirm that at 1-year, the EVOQUE TTVR system delivers superior clinical benefit versus medical therapy alone and consistent TR elimination. EVOQUE remains the world’s first and only approved TTVR system, approved in the US and Europe.
“These are important advancements for structural heart disease patients,” said Bernard Zovighian, CEO. “Consistent with our strategy, the combination of new clinical evidence, indication expansions and guideline changes enable improved clinical outcomes, expanded patient access and overall benefits to the healthcare system.”
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