First U.S. Patients Enrolled in the REALISM Continued Ac... ( MENLO PARK Calif. Feb. 2 /- Evalv...)

First U.S. Patients Enrolled in the REALISM Continued Access Study

Date:2/2/2009

MENLO PARK, Calif., Feb. 2 /PRNewswire/ -- Evalve, Inc., the leader in the development of devices for the percutaneous repair of cardiac valves, announced today the start of enrollment in the REALISM (Real World ExpAnded MuLtIcenter Study of the MitraClip(R) System) study, a continued access registry. The MitraClip(R) system is currently being evaluated in the United States 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.

MR affects millions of people worldwide and is the most common type of heart valve insufficiency in the United States and Europe. The vast majority of patients with significant MR are untreated, which leaves their hearts affected by the chronic volume overload caused by MR, requiring the heart to work harder, and ultimately leading to heart failure.

The first patient was enrolled in REALISM by Peter Fail, M.D., and his team at Terrebonne Regional Medical Center in Houma, Louisiana.

"Based on my experience treating patients with the MitraClip(R) system during EVEREST II, I am eager to participate in the REALISM study," said Dr. Fail, director of the cardiac catheterization lab and principal investigator at Terrebonne Regional Medical Center. "I often see patients who may be candidates for the MitraClip(R) therapy and I am glad they now have an option to participate in the continuation of this landmark trial and potentially benefit from this alternative treatment."

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 United States. Patients will undergo 30- d
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