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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

PARIS, May 25 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) today announced new data from the landmark EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) trial, which provide additional details about the safety and clinical benefit of Abbott's investigational MitraClip® system for the two causes of mitral regurgitation (MR) – functional MR (FMR) or degenerative MR (DMR). In the EVEREST II trial, the 30-day major adverse event rate in the MitraClip arm was similar for the FMR and DMR patient subgroups (8.2 percent for FMR patients, 8.1 percent for DMR patients), both lower than the surgical control group (42.6 percent). The MitraClip system also demonstrated consistent results in both FMR and DMR patients with both subgroups showing significant improvement at one year from baseline measures of heart function, symptoms and quality of life. These results were presented today during the Late Breaking Registries and Clinical Trial Updates session at the EuroPCR 2010 conference, and build upon the positive EVEREST II primary endpoint results that were presented during the American College of Cardiology 2010 meeting in March.

MR is the most common type of heart valve insufficiency and occurs when the leaflets of the mitral valve do not close completely, causing blood to flow backwards into the left atrium of the heart during the cardiac cycle. When patients are diagnosed with MR, they are usually classified as having functional MR or degenerative MR. Functional MR accounts for the majority of MR patients, and occurs due to heart muscle abnormalities caused by coronary artery disease or cardiomyopathy (a condition which causes the heart muscle to weaken). Degenerative MR is caused by deterioration of valve tissue.


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