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Texas Children's Hospital, Lead Study Center, Announces U.S. Food and Drug Administration Approval of EXCOR® Pediatric Ventricular Assist Device for Use in United States
Date:12/16/2011

able benefit of the pediatric heart pump. On July 21, 2011, Fraser led the IDE study team as they presented the final data to an FDA circulatory support advisory panel who unanimously recommended that the device be approved by the FDA. The final approval came on Dec. 16, 2011.

"It was a privilege to lead the many investigators, coordinators and administrative personnel involved in this study," said Fraser. "I know the hospitals and physicians who took part did it solely because it was the right thing to do on behalf of children who suffer heart failure."

About Texas Children's Hospital

Texas Children's Hospital, a not-for-profit organization, is committed to creating a community of healthy children through excellence in patient care, education and research. Consistently ranked among the top children's hospitals in the nation, Texas Children's has recognized Centers of Excellence in multiple pediatric subspecialties including the Cancer and Heart Centers, and operates the largest primary pediatric care network in the country. Texas Children's is completing a $1.5 billion expansion, which includes the Jan and Dan Duncan Neurological Research Institute; Texas Children's Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; and Texas Children's Hospital West Campus, a community hospital in suburban West Houston.  For more information on Texas Children's, go to www.texaschildrens.org. Get the latest news from Texas Children's by visiting the online newsroom and on Twitter at twitter.com/texaschildrens.

ABOUT BERLIN HEART

Berlin Heart GmbH is the only company worldwide that develops, produces, and distributes implantable and external ventricular assist devices for patients of every age and body si
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SOURCE Texas Children's Hospital
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