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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

September 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) therapy,” said Dr. Virmani. “These results are especially promising considering the potential need for future surgery in some patients. There are no histo-pathologic indications that suggest that future surgical options may be impaired in patients with long term implantation of the MitraClip(R) device.”

The MitraClip(R) system is the first commercially available treatment option for non-surgical mitral valve repair for patients suffering from the effects of MR in Europe. The MitraClip(R) system is currently in late stage clinical trials in the United States.

About Mitral Regurgitation

MR is the most common type of heart valve insufficiency in the United States and Europe, affecting millions of people worldwide. Significant MR affects more than eight million people in the US and Europe. There are more than 600,000 new diagnoses of significant MR each year in the US and Europe; however, only 20 percent of these patients undergo surgery each year. Many higher risk surgical patients and non-surgical patients continue to be affected by the chronic volume overload caused by MR, which requires the heart to work harder, and may ultimately lead to heart failure.

About the MitraClip(R) Procedure

Mitral repair with Evalve’s MitraClip(R) 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(R) 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.

Cofounded in 1999 by The Foundry and Dr. Fred St. Goar, Evalve, Inc., headquartered in Menlo Park, Calif., and has developed a proprietary system which enables percutaneous repair of cardiac valves. The company’s initial products are intended to reduce the risks, trauma and costs associated with current open, arrested heart surgical options. For more information about Evalve, Inc., and for an animated explanation of the procedure using the MitraClip(R) device, visit www.evalveinc.com. The MitraClip(R) system is currently undergoing clinical evaluation in the United States and Canada. Enrollment is ongoing in the REALISM study in the US, which allows EVEREST investigators and their patients continued access to the MitraClip(R) therapy during the PMA phase. The MitraClip(R) system is commercially distributed in Europe.

MitraClip(R) and Evalve are registered trademarks of Evalve, Inc.

    Media Contact:
    Heather Harper
    Edelman
    1-415-486-3233 office
    1-415-533-1001 mobile
    Heather.Harper@edelman.com

SOURCE Evalve, Inc.


Source: newswire



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