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Twin-to-Twin Transfusion Syndrome

U.S. FDA approves humanitarian device exemption for treatment of Twin-to-Twin Transfusion syndrome

Published in Blood Weekly, April 27th, 2006

The Food and Drug Administration (FDA) announced the approval of a Humanitarian Device Exemption (HDE) for Fetoscopy Instrument Sets distributed by Karl Storz Endoscopy America, Inc., Culver City, Calif. under the Humanitarian Use Device (HUD) program for the treatment of fetuses with twin-to-twin transfusion syndrome (TTTS).

TTTS is a rare disorder of the placenta that sometimes occurs when women are pregnant with identical twins. During the development of identical twins, blood vessels in the fetuses' shared placenta connect their blood circulations. In most cases, the blood flows properly through these vessels. However, in TTTS, the blood begins to flow unevenly,...

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