EFS of the CardioMech MVRS

Inclusion Criteria: * Eighteen (18) years of age or greater * Moderate to severe (≥3+) or severe (≥4+) mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines) due to mitral valve prolapse or flail * Intermediate or high surgical risk for mitral valve repair Exclusion Criteria: * History of rheumatic heart disease * History of prior endocarditis * History of prior repair or replacement of the mitral valve, or annuloplasty * Severely calcified mitral leaflet or has evidence of calcification in the grasping area of the leaflets that would prevent leaflet anchor positioning and deployment * Complex mechanism of MR (leaflet perforation, severe leaflet calcifications, commissural extension, commissural prolapse, multiple flail or prolapsing segments, cleft) present on required imaging