Annular Reshaping of the Mitral Valve for Patients With Mitral Regurgitation Using the Millipede IRIS System

Inclusion Criteria:

• Presence of symptomatic severe MR (effective regurgitant orifice (ERO) ≥0.2 cm2 for Secondary MR, ERO ≥0.4 cm2 for Primary MR)
• The New York Heart Association Functional Class II, III or ambulatory IV.
• Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50%
• Creatine Kinase-MB (CK-MB) obtained within prior 14 days \< local laboratory -Upper Limit of Normal (ULN).
• Left Ventricular End Systolic Dimension (LVESD) is ≤ 65 mm assessed by TTE obtained within 90 days Exclusion Criteria: -Untreated clinically significant coronary artery disease requiring revascularization.

Presence of any of the following:

• Estimated pulmonary artery systolic pressure (PASP) > 70 mmHg assessed by site based on echocardiography or right heart catheterization
• Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
• Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)
• Hemodynamic instability requiring inotropic support or mechanical heart assistance.
• Hemodynamic instability defined as systolic pressure \< 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.
• Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction.
• Coronary artery bypass grafting (CABG) within 30 days prior to subject's consent.
• Percutaneous coronary intervention within 30 days prior to subject's consent.
• Tricuspid valve disease requiring surgery.
• Aortic valve disease requiring surgery or TAVI.
• Carotid surgery within 30 days prior to subject registration.
• Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac -Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within the last 30 days prior to subject registration.
• Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
• Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure.
• Status 1 heart transplant or prior orthotopic heart transplantation.
• Chronic Kidney Disease.
• Chronic Steroid Therapy.
• Cerebrovascular accident within 30 days prior to subject's consent.
• Severe symptomatic carotid stenosis (> 70% by ultrasound).Life expectancy \< 12 months due to non-cardiac conditions.
• Active infections requiring current antibiotic therapy.
• Pregnant or planning pregnancy within next 12 months.
• Currently participating in an investigational drug or another device study.
• Severe organic lesions with mitral chords retraction, severely fibrotic and immobile leaflets, severely deformed subvalvular apparatus.
• endocarditis or active endocarditis in the last 3 months.
• Heavily calcified annulus or leaflets, mitral valve stenosis.
• Congenital malformation with limited valvular tissue
• Patient requires mitral valve replacement
• Previously implanted prosthetic mitral valve or annuloplasty ring/band.
• Evidence of LV or LA thrombus, vegetation or mass
• Left Ventricular Ejection Fraction \<20%
• Left Ventricular End Diastolic Diameter >65 mm
• Severe tricuspid regurgitation or severe RV dysfunction
• Condition that prevents transatrial access or transfemoral access
• Anatomical ineligibility to the investigational device
• Known hypersensitivity or contraindication to procedural or post procedural medication (e.g., contrast solution, anticoagulation therapy) or hypersensitivity to nickel or titanium.