Edwards Lifesciences Reports Positive Trial Results for SAPIEN M3 and EVOQUE Valve Systems

Reuters
2025.10.27 19:06
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Edwards Lifesciences Corporation announced positive clinical results for its SAPIEN M3 and EVOQUE valve systems. The ENCIRCLE trial demonstrated that the SAPIEN M3 TMVR system met all safety and effectiveness endpoints, showing low rates of death and heart failure hospitalization. Additionally, the EVOQUE system's 30-day data indicated better outcomes than the TRISCEND II trial. These findings were presented at the TCT 2025 symposium, with the SAPIEN M3 approved in Europe and the EVOQUE system approved in both the US and Europe.