The FDA authorises device that treats babies with oesophageal defects

The Flourish Pediatric Esophageal Atresia Anastomosis, from Cook Medical, is said to be a first-of-its-kind medical device to treat infants up to one year old for a birth defect that causes a gap in their oesophagus, called oesophageal atresia.

An estimated 1 in every 2,500 babies in the US is born with oesophageal atresia. Babies with this condition cannot feed normally, and they require a feeding tube until surgery can be performed to attach the oesophagus to the stomach.

“This new device provides a non-surgical option for doctors to treat oesophageal atresia in babies born with this condition,” said William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “But it is only intended for infants who do not have a tracheoesophageal fistula or who have had the fistula repaired in a prior surgery.”

The device uses magnets to pull the upper and lower oesophagus together, closing the gap and allowing food to enter the stomach. It is not for use in infants who also have a tracheoesophageal fistula, an abnormal connection between the oesophagus and the windpipe (trachea).

During the procedure to insert the Flourish device, doctors insert two catheters, one through the mouth and one through the stomach. The magnetic ends of the two catheters attract each other, and this attraction pulls the two ends of the oesophagus together over several days, closing the gap and forming a connection. Once the catheters are removed, the infant can begin to feed by mouth.