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Evalve Enrolls First US Patient In REALISM Continued Access Study

Evalve, Inc. has announced the first US patient enrollment in the REALISM (Real World ExpAnded MuLtIcenter Study of the MitraClip System) study, a continued access registry. The device is currently being evaluated in the US as a non-surgical treatment option for patients suffering from the effects of mitral regurgitation (MR). EVEREST II, the only randomized trial comparing a percutaneous mitral repair device to mitral valve surgery, successfully completed enrollment in 2008. Peter Fail, M.D., and his team at Terrebonne Regional Medical Center in Houma, Louisiana enrolled the first patient in the REALISM study. The REALISM study is a prospective, multi-center, continued access registry of the EVEREST II study. The REALISM study consists of two arms: a high risk arm and a non-high risk arm. Up to 300 patients will be enrolled in the study at clinical sites in the US. Patients will undergo 30- day, 6-month and 12-month clinical follow-up. REALISM will collect new information regarding functional capacity following treatment with the MitraClip device.