Transcatheter mitral valve repair (TMVR) with a device approved by the U.S. Food and Drug Administration (FDA) for use in mitral valve repair may be considered medically necessary for individuals with symptomatic, primary mitral regurgitation (MR) who are considered at prohibitive risk for open surgery (see Policy Guidelines section).
TMVR with a device approved by the U.S. FDA may be considered medically necessary for individuals with heart failure and moderate-to-severe or severe symptomatic secondary MR despite the use of maximally tolerated guideline-directed medical therapy (see Policy Guidelines section).
TMVR is considered investigational in all other situations.
