Edwards Lifesciences鈥� transcatheter aortic valve replacement (TAVR) system has demonstrated positive results in a long-term trial readout, as global demand for the technology increases.
The company shared seven-year data from its PARTNER 3 (NCT02675114) trial, reaffirming the early and sustained benefit of its SAPIEN 3 TAVR system in low-risk patients with aortic stenosis compared to surgery.
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The life sciences giant presented the data during a late-breaking session at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) meeting,聽taking place in San Francisco on 25-28 October. According to Edwards, data from PARTNER 3鈥檚 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, the data showed statistically comparable long-term valve performance between SAPIEN 3鈥檚 application in TAVR and SAVR. Valve durability indicators remained stable over time, with minimal variance in difference in valve failure, at 6.9% and 7.3% among the cohorts, respectively, with reintervention rates at 6% and 6.7%, respectively.
Both all-cause and cardiovascular mortality rates were similar between cohorts, with significant improvements in health status and quality of life after treatment with SAPIEN 3 TAVR and SAVR were sustained.
Martin Leon, professor of medicine at New York-Presbyterian Columbia University Irving Medical Center and co-principal investigator on the PARTNER 3 trial, said: 鈥淭he PARTNER trials set out to determine whether TAVR could be a safe and effective, less invasive alternative to surgery.
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By GlobalData鈥淚n the PARTNER 3 low risk trial, we again see the early clinical benefit of TAVR with SAPIEN 3 over surgery, as well as excellent long term valve performance and durability results for both therapies at seven years, which should be reassuring to patients and their physicians.鈥�
During TCT, Edwards also shared results from its PARTNER Trial series, including the ten-year follow up of more than 3,000 intermediate-risk patients from PARTNER 2 (NCT01314313) and PARTNER 2 S3i. The company stated these studies also demonstrated longer-term valve performance, durability and consistent clinical outcomes of SAPIEN 3.
Edwards’ TAVR corporate vice-president Dan Lippis commented: 鈥淚nsights from the PARTNER Trial series are foundational to TAVR, inspiring confidence in the procedure, advancing the therapy and fuelling structural heart innovation.
鈥淭hese latest findings reinforce the undeniable early benefits of TAVR and validate its long-term durability, matching surgery in key outcomes. We remain committed to advancing the science of aortic valve disease 鈥� including symptomatic and asymptomatic severe stenosis, as well as moderate stenosis 鈥� to transform care for patients worldwide.鈥�
吃瓜黑料网 from GlobalData suggests that Edwards Lifesciences continued to see sales momentum in July 2025, with the SAPIEN 3 product lines making up a large share of sales. The company currently holds more than 60% of global TAVR market share and 75% in the US, according to GlobalData estimates.
The TAVR market is projected to see a compound annual growth rate (CAGR) of 8% worldwide between 2024 and 2034, with the US market forecast to grow at a 6% CAGR during the same period.
