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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

ter implanted its first Berlin Heart on Sept. 27, 2005 in one of the smallest babies to ever receive the device. Brady Burch, a Corpus Christi resident, is now 6 years old and in kindergarten.  Fraser, who has long advocated that babies need small heart assist devices sized just for them, became proactively involved. He accompanied Berlin Heart representatives to Washington, requesting that the FDA allow an IDE study. The FDA agreed to open a study. The first pediatric patient was enrolled in November 2007.

Study background

In January 2008, Texas Children's was named the national lead center for a 12-hospital, 36-month clinical trial of the Berlin Heart EXCOR Pediatric VAD. Fraser was selected as the National Principal Investigator (NPI) for the IDE prospective study. In 2009, five other hospitals were added to the study.

The EXCOR® pediatric clinical study is the first prospective clinical trial ever conducted to investigate the safety and benefit of a VAD in the pediatric population. Between 2007 and 2010, the study enrolled 48 patients in two cohorts of 24 patients each. Another 200 patients were enrolled in a "compassionate use" cohort.  Along with Texas Children's Hospital, the following U.S. centers participated in the IDE study: Arkansas Children's Hospital (AR), Boston Children's Hospital (MA), Children's Healthcare of Atlanta (GA),Children's Hospital of Wisconsin (WI), The Children's Hospital of Denver (CO), Lucille Packard Children's Hospital at Stanford (CA), Mott Children's Hospital (MI), Mount Sinai Hospital (NY), Pittsburgh Children's Hospital (PA), Riley Children's Hospital (IN), Seattle Children's Hospital (WA), St. Louis Children's Hospital (MO), Children's Hospital at the University of Alabama at Birmingham (AL), and the University of Minnesota at Fairview (MN).

As NPI, Fraser worked in cooperation with all 17 hospitals in collecting and reporting data to the FDA regarding the safety and prob
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