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Abbott's Investigational MitraClip(R) System Demonstrates Strong Safety Results and Improved Clinical Outcomes for Common Causes of Leaky Heart Valves
Date:5/25/2010

The patient subgroup analysis included 135 patients with DMR and 49 patients with FMR. At one year, the MitraClip procedure demonstrated the following results in FMR and DMR patients:

  • An improvement in heart function as indicated by a reduction in both left ventricular end diastolic volume (LVEDV) and left ventricular end systolic volume (LVESV). In FMR patients, LVEDV decreased 10.6 percent and LVESV decreased 7.7 percent compared to baseline. Similarly, in DMR patients, LVEDV decreased 15 percent and LVESV decreased 6.7 percent compared to baseline.
  • An improvement in symptoms, with 96.7 percent of FMR patients and 97.8 percent of DMR patients exhibiting no symptoms (NYHA Functional Class I) or mild symptoms (NYHA Functional Class II), whereas at baseline, 64.5 percent of FMR patients and 45.2 percent of DMR 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 1.6 points for FMR patients and 5.6 points for DMR patients in the physical quality of life score, and increase of 8.7 points for FMR patients and 5.0 points for DMR patients in the mental quality of life score).

About Mitral Regurgitation

MR is the most common type of heart valve insufficiency in the United States and Europe, affecting millions of people worldwide. MR affects more than 8 million people in the United States and Europe. There are more than 600,000 new diagnoses of s
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