During his presentation at the J.P. Morgan Healthcare Conference, Edwards Lifesciences CEO Bernard Zovighian highlighted the culmination of many strategic aims for the company that occurred in 2025 along give it a strong positive outlook towards future performance.
There is a focus on expanding the structural heart portfolio based on unaddressed patient need and delivering value based on innovation and clinical evidence, two areas where Edwards has excelled.
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Edwards is best known for transcatheter aortic valve replacement (TAVR), a minimally invasive way to treat aortic stenosis that has steadily expanded from high-risk patients to much broader populations. Zovighian expects this trend to continue, with asymptomatic aortic stenosis patients being a key population going untreated in the US that could be addressed by the National Coverage Analysis initiated by the Centers for Medicare & Medicaid Services on December 24, 2025. The results from clinical studies EARLY TAVR and PARTNER 3 present compelling evidence for a positive shift in TAVR guidance. GlobalData has watch the rapid growth and success of TAVR devices, and the latest modelling of this segment shows Edwards at a commanding $4.53 billion in revenue with over 60% market share.
The transcatheter portfolio offered by Edwards has seen huge milestones accomplished as a result of sustained R&D investments and successful clinical trials. Transcatheter tricuspid valve replacement (TTVR) device EVOQUE received European approval in October 2023 and US approval in February 2024, being the first and only device in both markets. Transcatheter mitral valve replacement (TMVR) device Sapien M3 received European approval in April 2025 and US approval in December 2025, joining the Abbott Tendyne in the market but with an attractive transseptal approach rather than transapical. It is still unclear if these devices will match the success seen in the TAVR market, but Zovighian highlights the significant opportunity granted by moving early and working directly with practitioners to help patients previously unaddressed.
On 9 January, it was announced the Federal Trade Commission (FTC) injunction to prevent Edwards’ acquisition of JenaValve was being granted, effectively halting the deal due to monopolistic concerns. JenaValve’s Trilogy Heart Valve is a leading TAVR-AR device that faces competition from the J-Valve of JC Medical, an Edwards subsidiary. Both devices are available in Europe while seeking market approval in the US. Zovighian expressed disappointment but respect for the decision, noting that while acquisitions have always been an effective tool, Edwards relies on them less for growth than other medtech companies.
Going forward, it appears that Edwards is poised to see continued success in the burgeoning structural heart segment, which it is also driving. The company is targeting 10% growth in 2026 and has raised expectations from the same time last year as hitting these milestones has significantly de-risked the outlook. It remains to be seen whether these devices will follow the enviable trajectory of TAVR adoption, but the unaddressed patient populations and strong commitment to clinical evidence will give Edwards Lifesciences the opportunity to prove value to practitioners, patients, and public health regulators.
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