Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR

A Study to Evaluate the Feasibility and Safety of Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With Functional Mitral Regurgitation

Patients with functional mitral regurgitation classified as moderate to severe (3+) or severe (4+) that are symptomatic (NYHA Class II-IV) will be evaluated for treatment using the CathHELIX Transcatheter Mitral Annuloplasty System.

Inclusion Criteria:

• Moderate to severe (3+) or severe (4+) functional mitral regurgitation
• Left ventricular ejection fraction ≥30%
• Symptomatic New York Heart Association (NYHA) Class II to IV).

Exclusion Criteria:

• Oxygen dependent for COPD
• Active or suspected endocarditis
• Severe symptomatic carotid stenosis
• Has undergone heart transplantation.
• Severe calcification of the mitral annulus or leaflets
• Coronary sinus anatomy that may preclude proper treatment with the device