Press Release - Mar 27, 2007
Clinical Trial Offers Minimally Invasive Procedure for Heart Valve Leak
Click here to see the WHDH-TV news coverage of this trial.
Boston, MA - Brigham and Women’s Hospital (BWH) is currently participating in the nation-wide EVEREST II clinical trial for patients with a serious heart condition known as mitral regurgitation (MR). MR is a condition where blood leaks backward through the mitral valve with each heartbeat. MR forces the heart to work harder to circulate blood and can result in shortness of breath, fainting, low blood pressure, fluid retention, fatigue, loss of appetite and/or a hacking cough that worsens when lying down.
The trial is investigating a minimally invasive mitral repair procedure using the MitraClip™ device (Evalve Inc.)to repair the heart’s leaking valve by bringing its leaflets together to improve blood flow.
“EVEREST II represents a unique and cooperative effort between cardiology, cardiac surgery, cardiac anesthesia and echocardiography,” said Dr. Andrew Eisenhauer, associate director of the Cardiac Catheterization Laboratory at BWH and principal investigator. “As a result of this teamwork, we can achieve a unique perspective on mitral regurgitation and its treatment so that patients can get the most appropriate care, even if they ultimately are not candidates for the trial.”
This new procedure is performed under general anesthesia and is far less complex than the standard method of correcting MR - open-heart surgery, which requires use of a heart-lung machine and stopping the heart to repair or replace the valve.
Dr. Michael Davidson, an investigator in the trial and a cardiac surgeon at BWH, explained, “Up to this point, surgery was the only option for patients with severe mitral regurgitation and this trial offers the chance to participate in a non-surgical method of repair. To date, over 200 MitraClip devices have been implanted in North America, and Brigham and Women's Hospital is the regional center in New England offering this trial.”
An estimated 4 million people in the U.S. have significant MR, with approximately 250,000 new patients diagnosed each year. There are no drugs that specifically treat or cure MR. Dr. Eisenhauer added, “The MitraClip may allow us to stave off surgery safely and manage patients' symptoms effectively.”
Patients interested in learning more about the trial or if they may qualify for treatment can call toll free 1-877-MY-MR-FIX or visit www.mitralregurgitation.org.
For more information, contact BWH Media Relations at (617) 534-1600 or BWHMediaRelations@partners.org. B-roll and animation video is available.
Brigham and Women’s Hospital (BWH) is a 747-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare System, an integrated health care delivery network. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 800 physician-investigators and renowned biomedical scientists and faculty supported by more than $400M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.
Evalve, Inc., developer and manufacturer of the MitraClip(TM), is currently conducting the pivotal EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) clinical research study evaluating the safety and efficacy of the MitraClip device versus 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 and the Company anticipates completing enrollment by the end of 2007. Patients are randomized 2:1 to receive the MitraClip device. Evalve recently announced initiation of a High Risk Registry as part of the EVEREST II study. The company plans to file a PMA (pre-market approval) application in the United States once all patients are followed for one year and to seek CE Mark approval in Europe in late 2007.
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 risks, trauma and costs 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.