Edwards Lifesciences (NYSE: EW) today announced new data demonstrating long-term benefits with its Sapien heart valve system.
Seven-year data from the PARTNER 3 trial reaffirmed the early and sustained patient benefits of Edwards’ transcatheter aortic valve replacement (TAVR) system. Data outlined superior clinical outcomes at one year, too, and demonstrated strong long-term valve performance and durability.
Separately, 10-year results from PARTNER 2 intermediate risk studies reinforced the company’s valve’s lasting performance and outcomes across all risk profiles and generations.
These data add to new long-term findings for the Evoque and Sapien M3 valves also shared at TCT today.
Edwards shared findings at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. Investigators published outcomes concurrently in The New England Journal of Medicine. The company says its seven-year analysis marks the most extensive clinical follow-up to date for low-risk TAVR and surgical aortic valve replacement (SAVR) patients.
At seven years, data showed statistically comparable long-term valve performance between Sapien 3 TAVR and SAVR. Sapien has become the most studied valve platform since its introduction more than 20 years ago. The Sapien 3 valve offers a treatment option for aortic stenosis, including without symptoms.
Edwards said valve durability indicators in the study remained excellent and stable over time. Investigators saw no difference in bioprosthetic valve failure (6.9% for TAVR vs. 7.3% for SAVR) or reintervention rates (6% vs. 6.7%). Both all-cause and cardiovascular mortality rates proved similar between cohorts. Sapien 3 and SAVR delivered significant, sustained improvements in health status and quality of life after treatment.
The company also said its 10-year follow-up features findings from more than 3,000 intermediate-risk patients. These studies demonstrate longer-term valve performance, durability and consistent clinical outcomes for Edwards TAVR.
“Insights from the PARTNER Trial series are foundational to TAVR, inspiring confidence in the procedure, advancing the therapy and fueling structural heart innovation,” said Dan Lippis, corporate VP of TAVR at Edwards. “These latest findings reinforce the undeniable early benefits of TAVR and validate its long-term durability, matching surgery in key outcomes. As the global leader in transcatheter valve therapy, we remain committed to advancing the science of aortic valve disease – including symptomatic and asymptomatic severe stenosis as well as moderate stenosis – to transform care for patients worldwide.”
