March 22, 2007 — Evalve, Inc., a privately held medical device company, has announced the FDA has approved a registry of up to 70 patients who are at high risk of mortality from surgical treatment for mitral regurgitation (MR) as part of its ongoing pivotal EVEREST Study (Endovascular Valve Edge-to-Edge REpair STudy). Previously, enrollment in the EVEREST study was only available to lower-risk patients recommended for surgery.
"The new registry study allows investigators the ability to offer higher- risk patients a less-invasive option for correcting mitral regurgitation," said Patrick Whitlow, M.D., director of Interventional Cardiology, and EVEREST II Principal Investigator at Cleveland Clinic.
"Many MR patients do not undergo surgery because they have other conditions that put them at significant risk for operative mortality and morbidity. Many of these higher-risk patients have been referred to the EVEREST study, but until now were not eligible to participate," said Ted Feldman, M.D., director of the cardiac catheterization lab at Evanston Hospital in Evanston, IL and EVEREST II Co-Principal Investigator.
An estimated four million people in the United States have significant (3 or 4 ) MR, with an annual incidence of 250,000 newly diagnosed patients. However, only 20 percent of these patients, or approximately 50,000, undergo surgery each year; the other 200,000, which includes the higher-risk patient population, undergo palliative medical therapy.
"Less invasive options are important for the higher-risk patients," said Nicholas Smedira, M.D., director for the Kaufman Center for Heart Failure, Cardiac Transplantation and Mechanical Circulatory Support at Cleveland Clinic. "Patients not only do better during non-invasive procedures, but they tend to recover quicker."
"Based on promising data to date, particularly with respect to safety, the MitraClip device may be a viable treatment option for these higher-risk patients," said Donald Glower, M.D., professor of cardiovascular surgery, Duke University Medical Center, and Co-Principal Investigator of EVEREST II. "The new registry provides higher-risk patients access to this technology for the first time."
To date, over 160 patients have been treated with a MitraClip device in the EVEREST clinical study. The ongoing randomized study arm of EVEREST II compares the safety and efficacy of the MitraClip device to open arrested heart surgery at over 40 sites in the United States and Canada. Patients are randomized 2:1 to receive the MitraClip device or standard mitral valve surgery.
For more information visit www.evalveinc.com.