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First U.S. Patients Enrolled in the REALISM Continued Access Study
Date:2/2/2009

ay, 6-month and 12-month clinical follow-up. REALISM will collect new information regarding functional capacity following treatment with the MitraClip(R) device.

"The REALISM study will allow patients suffering from the effects of MR to continue to have access to the MitraClip(R) therapy under a controlled protocol while data from the EVEREST II trial are being finalized," said Ted Feldman, M.D., director of the cardiac catheterization lab at Evanston Hospital and co-principal investigator of the EVEREST trial. "This will also allow us to observe the use of the MitraClip(R) system under real world conditions and will allow us to further study changes in functional capacity after successful treatment with the MitraClip(R) system."

"Initiating enrollment in REALISM is an important milestone for Evalve," said Ferolyn Powell, president and chief executive officer of Evalve. "REALISM allows participating EVEREST investigators continued access to the MitraClip(R) therapy for patients suffering from MR. As we make progress toward filing the MitraClip(R) system premarket approval application with the FDA, this study also allows physicians to gain additional experience with the system and enables patients to potentially benefit from a less invasive treatment option."

The MitraClip(R) system is the only commercially available treatment option for non-surgical mitral valve repair in Europe.

About the MitraClip(R) Procedure

Percutaneous mitral repair with Evalve's MitraClip(R) system is performed by physicians in the catheterization laboratory. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine. In addition to improving blood flow through the heart, the procedure may also relieve symptoms such as fatigue and shortness of breath that often affect patients with significant MR. After treatment, patients generally recover quickly. The
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SOURCE Evalve, Inc.
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