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Abbott Laboratories' Minimally Invasive MitraClip System for Mitral Regurgitation Demonstrates Positive Clinical and Quality-of-Life Results for Patients Too High Risk for Surgery

Sunday, 10 Mar 2013 11:30am EDT 

Abbott Laboratories announced data from the EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High Surgical Risk cohort evaluating the Company's first-in-class catheter-based MitraClip() System for the treatment of mitral regurgitation (MR). Findings were presented at the 62nd Annual Scientific Session of the American College of Cardiology in San Francisco. Abbott's MitraClip system, an investigational device in the United States, received CE Mark in 2008 and is commercially available in approximately 30 countries, with more than 8,000 patients treated to date. The device is delivered to the heart through the femoral vein, a blood vessel in the leg, and is designed to reduce MR by clipping together the leaflets of the mitral valve to allow the heart to more efficiently pump blood. The EVEREST II High Surgical Risk cohort included data from patients enrolled in the multi-center EVEREST II High Risk and REALISM continued access studies. Findings from 351 symptomatic U.S. patients deemed too high risk for open mitral valve surgery demonstrated: A 30-day mortality rate significantly lower than expected for surgery (4.8% for patients treated with the MitraClip system versus 18.2% predicted surgical mortality, p<0.0001); A low rate of adverse events, despite the high surgical risk profile of the patients. 

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