Healthcare Industry News: circulatory support
News Release - March 19, 2007
High Risk Patients Gain Access to Percutaneous MitraClip(TM) Device to Reduce MRExpansion of EVEREST study to include High Risk Patients
Cleveland Clinic Foundation Treats First Patient in New Registry
Over 160 Patients Treated to Date
MENLO PARK, Calif., March 19 (HSMN NewsFeed) -- Evalve, Inc., a privately held medical device company, today announced the U.S. Food and Drug Administration (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.
About the MitraClip Procedure
Evalve's Percutaneous Mitral Repair is performed by interventional cardiologists 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 return to normal activity within one week. The MitraClip device appears to improve quality of life and help MR patients avoid or delay surgery, preserving surgical options (valve repair or replacement) if it becomes necessary.
"This high-risk registry is an exciting development for our technology, clinicians and patients because we believe it will generate valuable data to guide future treatment decisions for this highly underserved patient population," said Ferolyn Powell, Evalve's President and Chief Executive Officer. "Completion of the randomized study remains our top priority and we are on track to complete the pivotal randomized study enrollment by the beginning of 2008. We also anticipate CE Mark approval for the MitraClip device in Europe by the end of 2007."
About Mitral Regurgitation
MR, the most common type of heart valve insufficiency, occurs when the heart's mitral valve does not close properly. Blood leaks backward through the mitral valve with each heartbeat, causing the heart to work harder to circulate oxygen to the body. Both the American Heart Association and the American College of Cardiology recommend open-heart surgery to repair or replace the mitral valve for patients who suffer from chronic moderate to severe (3+) and severe (4+) MR.
For more information about mitral regurgitation or the EVEREST II study, please visit http://www.mitralregurgitation.org.
Evalve was incorporated in 1999 to design, develop, manufacture, and market innovative devices to enable percutaneous repair of cardiac valves. The company's initial products are intended to reduce the risk, trauma and cost associated with current open, arrested heart surgical options. The company's present development and clinical efforts are focused on mitral valve repair. For more information about Evalve, Inc., visit http://www.evalveinc.com.
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