The PALMETTO Study

Prospective, single-arm, multicenter, non-randomized early feasibility study

Key Inclusion Criteria: * Age greater than 18 years * Mitral regurgitation ≥ 3+ documented by echo * Symptomatic New York Heart Association (NYHA) Functional Class II-IVa despite optimal medical therapy for at least 30 days Key Exclusion Criteria: * Severe tricuspid valve pathology with \> moderate tricuspid regurgitation. * Greater than moderate RV dysfunction * Significant aortic valve regurgitation greater than moderate and or stenosis greater than moderate * Prior cardiac surgery or intervention, within 6 months that would prohibit the implant of the Palmetto Valve as determined by the screening committee * Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months * Pregnant or planning pregnancy within next 12 months * Currently participating in an investigational drug or another device study * Known hypersensitivity or contraindication to iodinated contrast media, aspirin, heparin, bivalirudin, or warfarin, where no adequate alternative therapy is available to support the required intraprocedural anticoagulation and the minimum six-month post-procedural anticoagulation regimen * Pre-existing hemodynamically significant pericardial effusion requiring intervention at the discretion of the multidisciplinary heart team