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Evalve Announces CE Mark Approval of the World's First Percutaneous Valve Repair System

reated more than 300 patients with close

to 400 MitraClip devices implanted. Trial data continues to grow with

a significant amount of three-year follow up results available as well

as four-year data from some patients.

-- Presentation of MitraClip Procedure Results: Data regarding the

positive results in functional MR (ischemic and cardiomyopathy)

patients will be presented by James Hermiller, M.D., director of the

interventional fellowship program at St. Vincent Heart Center of

Indiana in Indianapolis, at the SCAI-ACCi2 annual meeting in Chicago

as part of the late-breaking clinical trial program on Tuesday,

April 1. In addition to the data presentation, Evalve is sponsoring a

breakfast symposium organized by SCAI on Monday, March 31 where

MitraClip device data will be reviewed. The "Understanding Mitral

Regurgitation" symposium is being chaired by Ted Feldman, M.D.,

national principal interventional cardiology investigator for the

EVEREST study.

"The progress we have made, notably the milestones achieved in the EVEREST trial and receiving CE Mark approval, are important as we move toward commercialization in Europe and the U.S.," said Ferolyn Powell, president and chief executive officer of Evalve. "We believe the MitraClip system has the potential to benefit patients who currently suffer from the serious effects of MR. Oftentimes patients in consultation with their doctors choose not to undergo surgical treatment because of the associated risks and trauma. However, until now surgery was the only available treatment option. The MitraClip offers the patients a new alternative."


EVEREST investigators are currently enrolling patients in the randomized arm of the study with the goal of completing enrollment by the end of 2008.
Enrollment in the study is open to several patient

SOURCE Evalve, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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