FDAnews Device Daily Bulletin

FDA APPROVES HUMANITARIAN DEVICE EXEMPTION

April 5, 2006
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The FDA has approved a humanitarian device exemption (HDE) for Fetoscopy Instrument Sets, distributed by California-based Karl Storz Endoscopy America, under the Humanitarian Use Device program. It is used in the treatment of fetuses with twin-to-twin transfusion syndrome (TTTS).

TTTS is a rare disorder of the placenta that can occur 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 TTTS, the blood begins to flow unevenly, with one fetal twin receiving too much blood (the recipient) and the other receiving too little (the donor) blood. This can cause heart failure in the recipient twin and life-threatening anemia in the donor twin. Many of these babies do not survive delivery or are born with severe handicaps.

"This medical device gives doctors a new option for treating twin-to-twin transfusion syndrome," said Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. "It can help prolong the mother's pregnancy and improve the odds of survival, with reduced complications, for one or both twins."

The instruments are intended to be used for fetuses whose gestational age is between 16 and 26 weeks. The sets consist of a fetoscope (telescopic camera used to view a fetus) and sheaths which are used to pass other surgical instruments and fluid through the entry site.