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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

unction. Left ventricular diastolic volumes decreased a significant 13 percent (p<0.0001) and left ventricular diastolic dimensions decreased a significant 6.4 percent (p<0.0001) compared to baseline.
  • An improvement in symptoms, with 97.5 percent of patients exhibiting no symptoms (NYHA Functional Class I) or mild symptoms (NYHA Functional Class II) [p<0.0001], whereas at baseline, 52.6 percent of patients had moderate symptoms (NYHA Functional Class III) or severe symptoms (NYHA Functional Class IV). Patients who are classified as NYHA Functional Class III or IV experience marked or severe limitations in physical activity.
  • Meaningful improvements in both physical and mental quality of life compared to baseline as measured by the SF-36 Survey (increase of 4.7 points in the physical quality of life score [p<0.0001] and increase of 5.8 points in the mental quality of life score [p<0.0001]).

  • "The EVEREST II safety and effectiveness results support the MitraClip device as a treatment choice, and show that MitraClip patients still have the option for successful mitral valve surgery afterward if needed," said Donald Glower, M.D., professor of surgery, Cardiovascular and Thoracic Surgery Division, Duke University School of Medicine, Durham, NC; and co-principal investigator of the EVEREST II trial. "The improvements in symptoms, quality of life and cardiac function shown in the EVEREST II trial suggest the MitraClip procedure may be another valuable treatment option for certain patients with significant MR."


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