Healthcare Industry News: Evalve
News Release - March 26, 2007
Evalve's Percutaneous MitraClip(TM) Device Results in Significant Reverse Left Ventricular RemodelingAlternative to Major Open-Heart Surgery for Mitral Valve Repair Shows Ongoing Durability at Initial Three Year Follow-up More than 200 MitraClip Devices Implanted
MENLO PARK, Calif., March 26 (HSMN NewsFeed) -- Evalve, Inc., a privately held medical device company, today announced data demonstrating that successful reduction of mitral regurgitation (MR) can be maintained for up to 36 months following treatment with the MitraClip device. The results at 12 months also show significant reverse left ventricular remodeling, indicating improved left ventricular function.
At 12 months, in patients who were successfully treated with a MitraClip device:
* Statistically significant reverse left ventricular remodeling was demonstrated;
* 86% of patients were free from mitral valve surgery; and
* 97% of patients had improved or stable NYHA Class, with 93% in Class I or II.
Importantly, ongoing durability was confirmed: all patients who had successful MR reduction at twelve months remain surgery free with MR 2+ or less at two years.
"The significant reverse remodeling of the left ventricle observed at twelve months tells us that the heart responded favorably to repair with the MitraClip device. The improvement in NYHA Class, also observed at twelve months, correlates with the observed improved function of the left ventricle," said Blase Carabello, M.D, Chief of Medical Service at the Veterans Affairs Medical Center/Baylor College of Medicine in Houston TX. "The comprehensive echocardiographic analysis of the EVEREST trial will show us more about how the left ventricle responds to both percutaneous and surgical treatment of mitral regurgitation."
"Percutaneous repair with the MitraClip device is demonstrating its potential value as an alternative to open-heart surgery for the treatment of mitral regurgitation in selected patients and has shown encouraging midterm durability," said Dr Feldman, EVEREST II Co-Principal Investigator. "The EVEREST trial, the only trial of its kind in the world, is now also studying the use of the MitraClip device in patients at higher risk for surgical mortality."
"With over 200 MitraClip devices implanted to date, we are gaining experience and our ability to reduce mitral regurgitation is increasing. The MitraClip device provides a minimally invasive option to reduce mitral regurgitation that still allows the patient to undergo a first surgical repair later if needed," added Donald Glower, M.D., professor of cardiovascular surgery at Duke University Medical Center and Co-Principal Investigator of EVEREST II.
About EVEREST II
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.
About the MitraClip Procedure
Evalve's Percutaneous Mitral Repair (PMR) 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 modified 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.
About Mitral Regurgitation
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 moderate to severe (Grade 3+) and severe (Grade 4+) MR. Patients who are interested in participation in the study can call 1-877-MY-MR-FIX.
An estimated 4 million people in the United States have significant (>2+) 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 remain affected by 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 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.
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