The FDA has authorized the use of Cook Medical’s device for the treatment of infants born with a defect that causes a gap in the esophagus. It was OK’d via the agency’s Humanitarian Device Exemption pathway.
The Flourish device is designed to treat esophageal atresia in infants up to one year old. The congenital defect, where the esophagus grows in two separate segments, makes it impossible for babies to feed normally. It is lethal unless it is treated, according to Boston Children’s Hospital. It is usually treated by surgically connecting the two ends of the esophagus. They are fed intravenously until the gap can be repaired.
Babies with the condition may also have a tracheoesophageal fistula, which can cause fluids from the esophagus to enter the airways and cause breathing problems.
"This new device provides a nonsurgical 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 statement. But it should only be used for infants who don’t have a tracheoesophageal fistula or have had the fistula surgically fixed.
The device works by magnetically pulling the two ends of the esophagus together, according to the statement. A physician inserts one catheter through the infant’s mouth and the other through the stomach. The magnetic ends of the catheter attract each other and this motion brings the two ends of the esophagus together over several days. The infant may be fed normally once the catheters are removed.
The device is not indicated for infants whose esophagus segments are more than 4 centimeters apart, according to the statement. Safety data from 16 patients showed that all 16 infants had their esophagus connect within three to 10 days after treatment. But 13 of them developed narrowing in their esophagus—which may also occur from traditional surgical repair—that needed another procedure.