FDAnews
www.fdanews.com/articles/108398-experimental-device-keeps-boy-rsquo-s-heart-pumping

Experimental Device Keeps Boy’s Heart Pumping

July 9, 2008
It’s been more than two months since Blake — bloated, battered and barely conscious —was brought into New York City’s Mount Sinai Medical Center with heart failure. … But now, thanks to an experimental device called the Berlin Heart, which the Food and Drug Administration has not approved for use in the United States, Blake is the active young boy he was before.
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