| Significant symptomatic mitral regurgitation (MR ≥3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation |
Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen |
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Active endocarditis of the mitral valve |
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Rheumatic mitral valve disease |
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Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus |
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Evaluable data regarding safety or effectiveness is not available for prohibitive risk DMR patients with an LVEF <20% or an LVESD >60 mm |
