Cardioband With Transfemoral Delivery System

Cardioband Adjustable Annuloplasty System For Transcatheter Repair of Mitral Valve Regurgitation

To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for repair of functional mitral regurgitation.

Inclusion Criteria:

• Age > 18 years
• Moderate to severe functional Mitral Regurgitation (MR)
• Symptomatic Patients (NYHA ClassII-IV) despite optimal medical therapy , including Cardiac Resynchronization (CRT) if indicated.
• Left Ventricle Ejection Fraction (LVEF) ≥ 25%, LVEDD ≤ 65mm
• Subject is high risk to undergo Mitral Valve (MV) surgery (as assessed by a surgeon and a cardiologist, at the site)
• Transseptal catheterization and femoral vein access is determined to be feasible
• Subject is able and willing to give informed consent and follow protocol procedures

Exclusion Criteria:

• Active bacterial endocarditis
• Severe organic lesions with retracted chordae or congenital malformations with lack of valvular tissue
• Heavily calcified annulus or leaflets
• Subjects in whom transesophageal echocardiography is contraindicated
• Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization
• CRT implant within 3 months prior to procedure
• Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
• Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 6 months or severe carotid stenosis (>70% by Ultra sound)
• Renal insufficiency requiring dialysis
• Life expectancy of less than twelve months
• Subject is participating in concomitant research studies of investigational products
• Mitral valve anatomy which may preclude proper device treatment
• Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and severe tricuspid regurgitation