FDA authorizes magnet-based birth defect treatment device

The FDA recently authorized Cook Medical’s Flourish Pediatric Esophageal Atresia Anastomosis to treat a birth defect in infants up to 1 year old who have gaps in their esophagus (esophageal atresia).

Esophageal atresia is a birth defect that occurs when a baby is born with part of the esophagus missing. Instead of the tube growing from the mouth to the stomach, it grows into 2 separate segments that do not connect. It affects 1 in 4,000 babies, according to Boston Children’s Hospital. Fluids from the esophagus can get into airways and interfere with breathing. Esophageal atresia is fatal if not treated.

“This new device provides a non-surgical option for doctors to treat esophageal atresia in babies born with this condition,” said William Maisel, M.D., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, in a press release. “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.”

Magnets pull the upper and lower esophagus together to close the gap in the Flourish Pediatric Esophageal Atresia Anastomosis. Once that is completed food can begin to enter the stomach.

Doctors insert two catheters through the mouth and through the stomach to insert the Flourish device. The magnetic ends attract and pull the ends of the esophagus together over several days to form a connection. Once the catheters are removed, the infant can start to eat through the mouth.

Data for the Flourish device was reviewed by the FDA through the humanitarian device exemption (HDE) process.

Flourish device data showed the results of 16 patients who had the device implanted. All of the infants had their esophagus joined successfully within 3 to 10 days with no remaining gap. 13 of the 16 patients ended up developing a complication that narrowed their esophagus and required a balloon dilation procedure, a stent or both to repair the damage.

The Flourish device is not intended for use in infants older than 1 year or who have teeth. It should also not be used in infants who have tracheoesophageal fistula or have esophageal segments that are more than 4 cm apart.

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