Safety and Early Feasibility Study of the Harpoon Medical Device (EFS)

Inclusion Criteria: * All subjects referred for mitral valve surgery * Presence of severe mitral regurgitation as read on an echocardiographic study performed within 60 days prior to procedure. Assessment of mitral regurgitation will be performed by the investigational site echocardiography laboratory and confirmed by the Core Echocardiography Laboratory using an integrative method. * Age \> 18 years * Estimated post-ePTFE cordal implantation coaptation surface is adequate in the judgment of the operating surgeon and the patient eligibility committee * Degenerative mitral valve disease * Subject is able to sign informed consent and able to return for follow-up and is capable of participating in all testing associated with this clinical investigation * Women of child-bearing potential have a negative pregnancy test * Able to sign informed consent Exclusion Criteria: * Age \< 18 years * Infective endocarditis * Anterior or bileaflet prolapse * Functional mitral regurgitation * History of Mediastinal Radiation * Inflammatory (rheumatic) valve disease * Requirement for concomitant cardiac surgery (e.g., coronary artery bypass grafting (CABG), aortic valve surgery, etc.) * Symptomatic coronary artery disease * Cardiogenic shock at the time of enrollment * ST segment elevation myocardial infarction requiring intervention within 30 days prior to enrollment * Evidence of cirrhosis or hepatic synthetic failure * Pregnancy at the time of enrollment (women of child bearing age should…