First Patients Treated in Italy With the Percutaneous MitraClip... (proposed to patients with severemitral r...)

First Patients Treated in Italy With the Percutaneous MitraClip(R) System

Date:10/21/2008

proposed to patients with severe mitral regurgitation with an expected benefit in terms of functional class improvement."

Evalve received CE Mark approval for the MitraClip system this year, and has worked with hospitals across Europe to establish training programs in support of the European roll out. Commercial sales started in September. Multiple European centers are in the process of scheduling treatments of the first groups of patients, in addition to the University Heart Center in Hamburg, Germany which announced completion of its first case earlier in October. These additional sites include Hospital San Rafaelle, Milan, Italy; and Cardiovascular Center Frankfurt, Frankfurt, Germany.

"The first procedures in Italy mark a notable milestone for people worldwide suffering from MR," said Ferolyn Powell, president and chief executive office of Evalve. "Until now, surgery was the only available treatment option for repairing the mitral valve in MR patients. The MitraClip system offers suitable patients a new alternative that allows them to avoid the associated risks and trauma of surgery."

About the MitraClip Procedure

Percutaneous mitral repair with Evalve's MitraClip device 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 MitraClip device may improve quality of life and may help MR patients avoid or delay surgery, having preserved surgical options (valve repair or replacement) should surgery become necessary.

About Evalve, Inc.

Founded in 1999, Evalve, Inc. -- headquartered in Menlo Park, California -- has developed a proprietary system which enables percutaneous repair
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SOURCE Evalve, Inc.
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