St. Jude Medical Percutaneous Mitral Valve Repair Study

Inclusion Criteria: * Subject has symptomatic or asymptomatic moderate (2+) or severe (3-4+) mitral regurgitation. * Subject has an ejection fraction (EF) ≥ 30%. * Subject is of legal age (≥18 years old). * Subject is planned to undergo surgical repair or replacement of the mitral valve for symptomatic or asymptomatic posterior leaflet mitral prolapse. Exclusion Criteria: * Subject requires a complex mitral valve repair or has isolated anterior prolapse. * Subject has mitral valve stenosis in which the annulus opening is \<10mm. Subject has valve disease other than mitral which requires surgical intervention. * Subject requires a concomitant procedure. * Subject has a pre-existing prosthetic valve in any position. * Subject had stenting or PCI within 6 months before the planned procedure, or is anticipated to require stenting or PCI within 6 months post-procedure. * Subject has calcification of the mitral leaflets or annulus which in the medical opinion of the surgical investigator would limit repair and /or implantation of the investigational device. * Subject has renal insufficiency or is on chronic dialysis. * Subject has had a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months. * Subject has a history of endocarditis or has active endocarditis. * Subject has a history of autoimmune disease. * Subject has significant known carotid artery disease. * Subject has an aorto-mitral angle of \<110 degrees. * Subject has hypertrophic ob…