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Abbott's Investigational MitraClip(R) System Demonstrates Strong Safety Results and Improved Clinical Outcomes for Common Causes of Leaky Heart Valves
Date:5/25/2010

an class="xn-location">Europe and is currently managed with drugs or open heart surgery, depending on an individual patient's severity of MR and risk factors. Significant MR is a debilitating condition where the heart's ability to function continues to deteriorate over time, and may lead to irregular heartbeat, heart failure, stroke, heart attack or death.

"Continued advancements in medical device technology are bringing more options and tremendous benefits to patient care. The MitraClip device is a novel treatment, and these preliminary data indicate the device has sustained mid-term benefits and can be an option for some patients with FMR or DMR," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular.

The MitraClip system received CE Mark in March 2008. In the United States, the MitraClip device is limited by federal law to investigational use only and is not available for sale. The MitraClip system is currently under review for approval by the U.S. Food and Drug Administration.

More About the EVEREST II Patient Subgroup Analysis

The EVEREST II trial is the first randomized trial of any minimally invasive mitral valve repair device compared to mitral valve surgery. The EVEREST II pivotal trial is a multi-center, randomized clinical trial of 279 patients with moderate-to-severe (3+) or severe (4+) mitral regurgitation who were candidates for mitral valve surgery. Patients were selected for treatment with the MitraClip device if they met the criteria for surgical intervention from the 1998/2006 American College of Cardiology (ACC)/ American Heart Association (AHA) Joint Task Force Recommendations regarding therapy for valvular heart disease.


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