Annuloplasty device for repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation. Unlike conventional annuloplasty ring, the Cardinal system offers the clinician the opportunity to make adjustments after weaning from cardiopulmonary bypass. Adjustability is expected to reduce the number of patients leaving the operating room with residual regurgitation after mitral valve repair.
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Percentage of Subjects with Valtech Cardinal Mitral Heart Valve Device Technical Success
Timeframe: Day of surgery
Percentage of Subjects with Successful Off Pump Adjustment of their Valtech Cardinal Mitral Annuloplasty Ring
Timeframe: Day of surgery
Subject's Mitral Valve Regurgitation (MR) Post-procedure as Compared to Baseline
Timeframe: At the end of the procedure on the day of surgery compared to baseline.
Subject's Mitral Valve Regurgitation (MR) at Discharge as Compared to Baseline
Timeframe: Day of discharge compared to baseline.
Subject's Mitral Valve Regurgitation (MR) at 30 Days as Compared to Baseline
Timeframe: 30 days compared to baseline.