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Texas Children's Hospital Hosts North American Investigators on Berlin Heart Trial
Date:10/21/2010

HOUSTON, Oct. 21 /PRNewswire-USNewswire/ -- Investigators from Texas Children's Hospital and 16 other top pediatric heart centers in North America came together in Houston to analyze results from their 39-month national clinical trial of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD), a German-manufactured pediatric mechanical heart.  To learn more about the study, see: http://bit.ly/bfrA1J

(Photo:  http://photos.prnewswire.com/prnh/20101021/DC86640)

(Photo:  http://www.newscom.com/cgi-bin/prnh/20101021/DC86640)

The conference, organized by the Berlin Heart Group, was hosted by National Principal Investigator, Charles D. Fraser, Jr., MD, surgeon-in-chief at Texas Children's Hospital and professor of Surgery and Pediatrics at Baylor College of Medicine. As NPI, Dr. Fraser leads the cooperative efforts of 15 U.S. hospitals and two Canadian hospitals in conducting the trial, collecting data and reporting the results to the United States Food and Drug Administration on the safety and probable benefit of the pediatric heart pump.

The study focuses on the Berlin Heart EXCOR Pediatric VAD, a mechanical cardiac support system for critically ill pediatric patients suffering from severe heart failure.  It comes in graduated sizes to fit a population from newborns to teens and is the only pediatric heart pump that provides medium-to-long-term mechanical circulatory support for infants and children awaiting heart transplantations.  The device has been approved in Germany and Europe since 1992 and the company is now seeking FDA approval for use in the U.S.

During the study, investigators enrolled 48 pediatric patients in the primary cohort groups and more than 100 pediatric patients in the "Compassionate Use" cohorts of the inve
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SOURCE Texas Children's Hospital
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