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Evalve Announces Enrollment Completion of the EVEREST Randomized Study
Date:9/30/2008

rcially available treatment alternative that enables non-surgical repair for MR.

"Randomized trials provide valuable insight into directing future studies to improve therapy and match new therapies to the appropriate patient," said Donald Glower, M.D., professor of surgery at Duke Medical Center and co-principal investigator of the EVEREST study. "This trial sets a high scientific standard for future percutaneous valve therapies. As a result, this trial will have a significant and long-lasting impact on patient care around the world."

Overall, EVEREST Investigators have treated more than 350 patients with over 450 MitraClip devices implanted. Clinical data continues to grow and a significant number of three-year follow up results are available as well as four-year data from a smaller group of patients.

Registry data from the initial non-randomized cohort of EVEREST patients continue to indicate MR reduction is maintained over time in the majority of patients, hospital stays are short, fewer complications occur compared to mitral valve surgery and surgical options are preserved if needed.

More information about the EVEREST trial is available at http://www.mitralregurgitation.org.

"This is an important achievement for Evalve on the path to meeting regulatory milestones with the FDA," said Ferolyn Powell, president and chief executive officer of Evalve. "We believe the MitraClip system has the potential to provide patients suffering with MR an important alternative to surgery that will allow them to avoid the associated risks and trauma."

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
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SOURCE Evalve, Inc.
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