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New Data Demonstrates Abbott's Investigational MitraClip(R) System Has Potential to be a Valuable Treatment Option for Patients With Mitral Regurgitation, the Most Common Heart Valve Condition
Date:3/14/2010

ed to surgical repair or replacement (9.6 percent of MitraClip patients and 57.0 percent of surgery patients had an MAE). Major adverse events is defined as a composite of 12 pre-specified adverse events. In the primary effectiveness endpoint, the MitraClip device was non-inferior to surgery at one year (clinical success rate of 72.4 percent for MitraClip patients with successful initial treatment compared to a clinical success rate of 87.8 percent for surgery patients). With 95 percent confidence, the clinical success rate of the MitraClip device falls within 25.4 percent of the clinical success rate of the surgical control. In the primary effectiveness endpoint, the clinical success rate is defined as freedom from death, surgery for valve dysfunction and moderate to severe MR (greater than 2+) at one year in patients with successful initial treatment.  

At one year, the MitraClip procedure demonstrated meaningful clinical benefits in the following secondary endpoints in patients with successful initial treatment:

  • A reduction in the severity of MR, with 81.5 percent of patients improving to mild (grade 1+) or moderate (grade 2+) MR whereas at baseline 95.6 percent of patients had moderate-to-severe (grade 3+) or severe (grade 4+) MR (p<0.0001).
  • A reduction in both the volume (left ventricular diastolic volumes) and the diameter of the left ventricle heart chamber (left ventricular diastolic dimensions), indicating an improvement in heart f
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SOURCE Abbott
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