Mitral valve replacement device, Sapien M3, earns CE marking for approval in Europe, under the leadership of Edwards.
In the rapidly evolving field of medical devices and cardiac topics, Edwards Lifesciences is making significant strides with its Transcatheter Mitral and Tricuspid Therapy (TMTT) portfolio. The company, which is currently seeing growth driven by the Pascal system for mitral valve repair and Evoque for tricuspid valve replacement, is looking to TMTT to support sales growth, especially as the larger transcatheter aortic valve replacement business slows.
One of the key components of this portfolio is the Sapien M3, a transcatheter mitral valve replacement system that has already received CE mark approval in Europe. This makes Edwards the first company to offer devices for both mitral and tricuspid valve repairs and replacements in the European Union. However, as of mid-2025, the Sapien M3 system has not yet received FDA approval in the United States.
The Sapien M3 system, which is designed for people with symptomatic mitral regurgitation who are unsuitable for surgery or transcatheter edge-to-edge therapy, is the world's first system to treat mitral regurgitation using a transfemoral approach. Edwards is aiming to win approval for Sapien M3 in the U.S. next year.
The Sapien M3's U.S. market entry, along with the predicted launch of Pascal tricuspid, is expected to significantly contribute to Edwards reaching $2 billion in TMTT sales by 2030. In fact, Edwards has forecast that TMTT sales will grow 50% to 60% this year to reach at least $500 million.
BTIG analysts are predicting TAVR sales will grow 3% in the first quarter, with TMTT sales stepping up in the third quarter, contributing to around 60% of their full-year forecast. Specifically, they are modeling TMTT sales of $114.5 million for the first quarter, around $2 million more than the consensus estimate of their peers.
Edwards CFO Scott Ullem sees mitral valve replacement as an important alternative for patients where transcatheter edge-to-edge repair may not be the best solution. The company will report on the commercial progress of its TMTT portfolio in its first-quarter results on April 23.
In summary, Edwards Lifesciences' Sapien M3 transcatheter mitral valve replacement system has received CE mark approval in Europe but has not yet received FDA approval in the United States. The company is building a multi-product TMTT portfolio, including Pascal mitral and tricuspid valve repair devices and the Evoque tricuspid valve replacement device, and is looking forward to the potential growth these products could bring, particularly with the anticipated FDA approval of Sapien M3.
- Edwards Lifesciences, with its Transcatheter Mitral and Tricuspid Therapy (TMTT) portfolio, is eagerly awaiting FDA approval for its Sapien M3 transcatheter mitral valve replacement system in the United States.
- The company, which has already received CE mark approval for the Sapien M3 system in Europe, anticipates that the U.S. market entry of this system, along with the launch of Pascal tricuspid, will significantly boost TMTT sales.
- According to Edwards' forecast, TMTT sales are projected to grow by 50% to 60% this year, aiming to reach at least $500 million.
- Analysts, such as those at BTIG, predict a 3% growth in TAVR sales in the first quarter, followed by a surge in TMTT sales in the third quarter, contributing to around 60% of their full-year forecast.
- By reporting on the commercial progress of its TMTT portfolio in its first-quarter results on April 23, Edwards will provide insights into the performance of these medical-devices in the health-and-wellness sector, particularly in the field of cardiovascular health.
- With the anticipated approval of Sapien M3, Edwards is positioning itself for potential growth in the medtech industry, offering devices for both mitral and tricuspid valve repairs and replacements in the European Union and preparing for a broader global market.
