Edwards is building a multi-product TMTT portfolio. The company received CE marks for its Pascal mitral and tricuspid valve repair devices in 2019 and 2020, respectively, and for the Evoque tricuspid valve replacement device in 2023. The CE mark for Sapien M3 means Edwards can now offer devices to repair and replace mitral and tricuspid valves in the European Union.

Edwards CEO Bernard Zovighian discussed the need for the portfolio approach at an investor conference in December. The patient population is “very complex, very diverse, large and growing,” Zovighian said. That led Edwards to go “big from the beginning,” the CEO said, by developing multiple devices in parallel. 

The company has predicted TMTT sales will grow 50% to 60% this year to reach at least $500 million. The Pascal system for mitral valve repair and Evoque for tricuspid valve replacement, which the Food and Drug Administration authorized in 2022 and 2024, respectively, are the current growth drivers. As Sapien M3 and Pascal tricuspid reach the U.S. market, Edwards is predicting sales will hit $2 billion by 2030.