St. Jude Medical Percutaneous Mitral Valve Repair Study
St. Jude Medical Percutaneous Mitral Valve Repair Study
The purpose of this proof-of-concept study is to assess the relative safety and feasibility
 of the SJM Percutaneous Mitral Valve Repair (PMVr) Device.
Subjects will be followed-up through 6 weeks post implantation.
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 obstructive cardiomyopathy (HOCM's Disease).