FDA Approves Device to Treat Rare Disorder of Identical Twin Fetuses

The Food and Drug Administration (FDA) today 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, with one fetal twin receiving too much blood (the recipient) and one receiving too little (the donor). 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. It can help prolong the mother’s pregnancy and improve the odds of survival, with reduced complications, for one or both twins,” said Dr. Daniel Schultz, Director of FDA’s Center for Devices and Radiological Health.

The Fetoscopy Instrument Sets are intended to be used for the treatment of TTTS 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. After identifying the communicating blood vessels on the placenta with the fetoscope, a laser can be passed through a sheath. The laser is used to photocoagulate (destroy with heat) the communicating vessels which should help to normalize the flow of blood between the twins. After all of the target vessels are identified and treated, the laser, fetoscope and sheath are removed.

The HUD program encourages the development of medical devices intended to treat or diagnose a disease or condition affecting fewer than 4,000 people in the U.S. per year. To receive approval of an HDE application, a sponsor must demonstrate that the safety and probable benefit of its device. Such products can only be used under the supervision of a local Institutional Review Board.


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