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Evalve Announces CE Mark Approval of the World's First Percutaneous Valve Repair System
Date:3/25/2008

MENLO PARK, Calif., March 25 /PRNewswire/ -- Evalve, Inc., the leader in the development of devices for the percutaneous repair of cardiac valves, announced today CE Mark approval for its MitraClip(R) system. The MitraClip is the first commercially available device which enables a non-surgical option for patients suffering from the effects of mitral regurgitation (MR).

MR is the most common type of heart valve insufficiency in the United States and the second most common in Europe, affecting millions of people worldwide. Both in the United States and Europe, the vast majority of patients 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.

CE Mark approval gives Evalve the ability to train and educate physicians in Europe on the use of the MitraClip device increasing the number of patients who will potentially benefit from this innovative treatment. Evalve will work with hospitals across Europe to establish training programs which will allow physicians to gain access to this new technology.
In addition to CE Mark approval, company highlights include:

-- High Risk Registry Study Arm Enrollment Completed: Evalve recently

completed enrollment in the high-risk registry arm of the Endovascular

Valve Edge-to-Edge REpair STudy (EVEREST) in North America. Patients

who are high risk surgical candidates may benefit from a less invasive

procedure. Investigators are collecting follow-up data to assess the

risk-benefit profile from the less invasive percutaneous intervention

with the MitraClip device.

-- Continued Progress with EVEREST Trial: The EVEREST investigators from

more than 40 sites across North America have reached additional

milestones in the ongoing FDA-approved Phase II clinical study.

EVEREST Investigators have t
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SOURCE Evalve, Inc.
Copyright©2008 PR Newswire.
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