In March 2025, the Centers for Medicare & Medicaid Services (CMS) finalized a National Coverage Determination (NCD) for transcatheter tricuspid valve replacement. This decision is a critical step in expanding patient access for Edwards Lifesciences' EVOQUE system among Medicare beneficiaries.
The finalization of the NCD follows Edwards' submission of a request in February 2024, after receiving FDA approval for its EVOQUE device. This regulatory action provides clarity and broadens the pathway for eligible patients to receive this innovative therapy.
The NCD is expected to significantly boost the adoption and commercial success of the EVOQUE system, which demonstrated superiority in the TRISCEND II trial. This development reinforces Edwards' leadership in the Transcatheter Mitral and Tricuspid Therapies (TMTT) market.
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