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National study will look at German-made heart pump for children needing heart transplants
Date:1/18/2008

ase-by-case basis. If approved, the Berlin Heart had to be flown from Germany while the child waited, possibly losing precious time. Also, under prior FDA regulations, the device could not be stored in the U.S., but had to be flown back to Germany if it was not used. Now with the IDE study in place, participating centers may keep the device on hand for easier access for their patients with failing hearts.

BACKGROUND

Physicians in Arizona implanted the first Berlin Heart in the U.S. in 2000. Later, a 4-month-old baby who received the Berlin Heart at Stanford University received high-profile media coverage in August, 2004. The coverage piqued interest in the Berlin Heart among pediatric hospitals around the country. Texas Childrens Heart Center implanted its first Berlin Heart on September 27, 2005 in one of the smallest babies to ever receive the device. Currently, Texas Childrens has implanted seven Berlin Hearts in infants and young children between the ages of two months to 12 years. Based on his experience with the device, Fraser, a strong advocate of small devices for babies, began working with representatives of the Berlin Heart company in submitting evidence to the FDA. On May 9, 2007, the FDA granted a Conditional Investigational Device Exemption approval that allowed for a multi-center study or clinical trial to be set up.


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Contact: Carol Wittman
cwittma@texaschildrenshospital.org
832-824-7243, ext. 5695
Texas Children's Hospital
Source:Eurekalert

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