Cardioband With Transfemoral Delivery System
Cardioband With Transfemoral Delivery System
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