Edwards Lifesciences predicted Wednesday that an expanded indication in transcatheter aortic valve replacement (TAVR) and rapid growth in its newer mitral and tricuspid heart valve technologies will accelerate total company sales in 2026 and beyond.
Edwards anticipates mid-2025 approval for TAVR in people with asymptomatic severe aortic stenosis, the company said during an investor day event.
The Sapien TAVR system is Edwards’ biggest product but has seen growth slow this year as hospital heart teams dealt with capacity constraints. Hospitals, however, are investing to increase capacity and avoid delays in patient treatment, which will support prioritization of aortic stenosis cases long term, Edwards said in its presentation.
The company expects approval for TAVR in asymptomatic patients to drive growth, after study results released in October showed benefits of early intervention with the procedure. Asymptomatic patients with severe aortic stenosis who received a Sapien valve had better outcomes in the trial than those who remained under routine clinical surveillance.
Edward executives see the data leading to revised treatment guidelines, which currently recommend clinical surveillance for patients without symptoms.
The company is also studying TAVR in patients with moderate aortic stenosis in the Progress trial. That study completed enrollment earlier this year, two years ahead of schedule, and a data release is targeted for the Transcatheter Cardiovascular Therapeutics conference in late 2026.
Longer term, Edwards executives said the company is developing a catheter-based treatment for aortic regurgitation, which it called the “next frontier” in aortic valve disease. Regurgitation is when blood leaks backward through the valve because it doesn’t close properly, whereas stenosis occurs when the valve opening narrows and restricts blood flow.
Beyond TAVR, Edwards is looking for fast growth in sales of its new devices to address mitral and tricuspid valve disease, driven by the Pascal mitral repair system and Evoque for tricuspid valve replacement.
The company expects to gain the CE mark in mid-2025 for Sapien M3, a transcatheter mitral valve replacement system, followed by U.S. approval in the first half of 2026. If approved in Europe, the device would become the first transcatheter mitral valve replacement system on the market. A pivotal trial is also underway studying Pascal in tricuspid patients.
Heart failure management is another focus. Edwards’ Cordella implantable pulmonary artery pressure sensor received U.S. approval in June, and the company is now building its commercial team and training doctors on the system.
For 2025, Edwards forecast TAVR sales will increase by a range of from 5% to 7%, excluding the impact of foreign currency fluctuations, to a range of from $4.1 billion to $4.4 billion. The outlook assumes TAVR for asymptomatic patients is approved mid-year.
Sales in transcatheter mitral and tricuspid therapies (TMTT) were projected to rise by a range of from 50% to 60%, to between $500 million and $530 million.
Edwards expects total sales growth of from 8% to 10% in 2025, the same rate it forecasts for 2024. It is targeting 10% average annual growth beginning in 2026.
In TMTT, Edwards said sales could hit $2 billion by 2030.