Cardiovalve Transfemoral Mitral Valve System

Inclusion Criteria: * 85\>Age ≥ 18 years * Symptomatic (Stage D) severe MR confirmed by the echo core lab * Cardiac Index \> 2.0 * Left Ventricular Ejection Fraction (LVEF) is ≥ 30% (within 90 days prior to subject enrollment based upon TTE) * New York Heart Association (NYHA) Functional Class II, III or ambulatory IVa * Prior treatment with Guideline Directed Medical Therapy (GDMT) for heart failure for at least 30 days prior to index procedure * Patient deemed a high surgical risk per MVARC definition by the site's Heart Team (as a minimum, one MV cardiac surgeon and one interventional cardiologist, and a cardiac imaging expert). Exclusion Criteria: * MR etiology that is exclusively Primary (degenerative) * Echocardiographic or angiographic evidence of severe mitral annular calcification * Echocardiographic evidence of EROA \< 0.3cm2 * Untreated clinically significant coronary artery disease requiring revascularization. * Hypertrophic/restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure other than other than cardiomyopathy of either ischemic or non-ischemic etiology * Hypotension (systolic pressure \< 90 mm Hg)/Cardiogenic shock or other hemodynamic instability requiring the need for inotropic * Fixed pulmonary artery systolic pressure \> 2/3 of systemic systolic blood pressure * LVEDD \>75 mm * Severe tricuspid regurgitation or evidence of severe right ventricular dysfunction. * Anatomy deemed not suitable for th…