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"This study is gathering valuable information that cardiac surgeons and interventional cardiologists have never had before. The data provides new insights about treatment considerations for patients with significant degenerative or functional mitral regurgitation," said Dr. Feldman. "We encourage physicians to refer such patients to EVEREST investigators."
Enrollment in the study is open to a range of patients:
-- Patients with either degenerative or functional MR.
-- Patients who are good surgical candidates and are open to the option of
a less invasive approach.
-- High risk patients who are not good candidates for surgery will be
enrolled in the EVEREST High Risk Registry until enrollment is complete
in this arm by the end of 2007.
More information about the EVEREST II trial is available at http://www.mitralregurgitation.org.
"Evalve remains focused on completing the EVEREST II trial and making progress toward commercialization of the MitraClip device," said Ferolyn Powell, president and chief executive officer of Evalve(R). "The data underscore that the MitraClip device has the potential to be a valuable alternative to treat patients with mitral regurgitation, providing a less invasive treatment option and enabling patients to avoid the trauma, long recovery times and complications associated with open heart surgery."
About EVEREST II
The EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) clinical
research study is evaluating the safety and efficacy of the MitraClip
device compared to surgical mitral valve repair or replacement. This
prospective, randomized, multi-center study will enroll 279 patients at up
to 42 sites in the United States and Canada. Patients are randomized 2:1 to
receive the MitraClip device. The same sites are also enrolling patients in
a High Risk Registry. Pat
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| SOURCE Evalve, Inc. Copyright©2007 PR Newswire. All rights reserved |