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Article Date: 01/18/2008

German-made Heart Pump for Children Undergoes National Study
The Berlin Heart EXCORŽ Pediatric Ventricular Assist Device (VAD), a German-manufactured pediatric heart pump, is under a clinical trial to determine whether Berlin Heart, Inc. will present those data to the FDA for consideration of approval of the EXCOR Pediatric VAD for use in the U.S. Texas Children’s Hospital has been named the national lead center for the12-hospital, 36-month clinical trial. The Berlin Heart EXCOR Pediatric VAD comes in many sizes - from newborns all the way up to teens. It is the only pediatric heart pump that provides medium-to-long-term mechanical circulatory support for infants and children awaiting heart transplantations. Although the device has been approved in Germany and Europe since 1992, it does not have FDA approval for use in the U. S. Along with Texas Children's Hospital, 11 hospitals will participate in the study: Arkansas Children’s Hospital, Little Rock; Boston Children’s Hospital; Children’s Hospital of Wisconsin in Milwaukee; Riley Children’s Hospital, Indianapolis; Mott Children Hospital, Ann Arbor; Lucille Packard Children’s at Stanford; St. Louis Children’s Hospital; Seattle Children’s Hospital; and Children’s Hospital at the University of Alabama at Birmingham. Stollery Children’s Hospital in Edmonton, and the Hospital for Sick Kids in Toronto are participating in Canada.

Website Address: http://www.eurekalert.org/pub_releases/2008-01/tch-nsw011808.php

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