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Data Show Long-Term Mechanical Integrity of MitraClip(R) and Complete Healing Following Implantation of the Device for Mitral Valve Repair
Date:9/22/2009

SAN FRANCISCO, Sept. 22 /PRNewswire/ -- The mechanical integrity of the MitraClip(R) device for repair of the mitral valve was maintained for up to five years and with complete healing, according to a subset of data from the EVEREST (Endovascular Valve Edge-to-Edge REpair STudy) study presented today at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco.

The data also show complete fibrous encapsulation of the MitraClip device with organized, endocardial tissue growth demonstrating complete healing and incorporation of the implant within the native mitral valve. Additionally, no significant stenosis or inflammation was observed beyond 300 days.

The data were presented today by Renu Virmani, M.D., president and Medical Director, CVPath Institute, Inc. The EVEREST study was designed to evaluate the MitraClip(R) system for the treatment of mitral regurgitation (MR).

In the EVEREST study, 16 MitraClip(R) devices were explanted greater than 300 days after implantation. During explant surgery, the fibrous capsule often requires dissection in order to perform surgical repair of the valve; Dr Virmani reports on three MitraClip(R) explants with minimal tissue disturbance. In these three MitraClip(R) explants, a fibrous tissue bridge with a mean thickness of 10.01 +/- 2.09mm was observed over and between the MitraClip(R) device arms resulting in tissue continuity between the two valve leaflets. Tissue growth over the MitraClip(R) device arms had a mean thickness of 0.82 +/- 0.74mm. There was no, or minimal, inflammation and no evidence of infection or stenosis. None of the16 long-term MitraClip(R) implants studied demonstrated any evidence of wear, component fracture or corrosion for up to five years.

"The long-term data demonstrate device integrity over time and healing as expected for patients that have received the MitraClip(R)
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SOURCE Evalve, Inc.
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