Clinical Research Directory

Key Inclusion Criteria: 1. Subject age ≥ 18-85 years at time of enrollment. 2. Symptomatic MR \> 3+ confirmed by echocardiographic core lab. 3. Primary segmental prolapse or flail of P2 segment only, or P2 segmental prolapse or flail extending to one adjacent segment (P1 or P3), and the primary regurgitant jet is non- commissural. 4. Left Ventricular Ejection Fraction (LVEF) is ≥30% (within 180 days prior to subject enrollment based upon TTE). 5. Cardiac symptoms present (NYHA Functional Class II, III, or ambulatory IVa) and a candidate for primary MR surgical repair (based on anatomical criteria). 6. Intermediate or high surgical risk based on per MVARC guidelines as determined by the site Heart Team and adjudicated by the Subject Screening Committee based. Key Exclusion Criteria: 1. MR etiology that is exclusively Secondary (functional). 2. Echocardiographic evidence of EROA ≤ 0.3cm2. 3. Untreated clinically significant coronary artery disease requiring revascularization. 4. Aortic, pulmonary, or tricuspid valve disease which is severe or greater, or requiring surgery. 5. Any prior mitral valve surgery or transcatheter mitral valve procedure. 6. Stroke, transient ischemic event, or myocardial infarction within 30 Days prior to index procedure. 7. Active endocarditis. 8. Pregnant or planning pregnancy within next 12 months. 9. Life expectancy \<1 year due to non-cardiac conditions including cancer. 10. Prior orthotropic heart transplant. 11. Currently participating in another investigational drug or device study and has not reached primary endpoint. 12. Known allergy or hypersensitivity to nickel, titanium or contrast dye or contraindication to procedural or post procedural medications (example aspirin, clopidogrel, heparin) which cannot be adequately managed medically.