FDA Allows Cook Medical Pediatric Esophageal Device on Market

FDA has authorized use (humanitarian device exemption) of Cook Medical’s Flourish Pediatric Esophageal Atresia Anastomosis, a device to treat infants up to one year old for a birth defect that causes a gap in their esophagus, called esophageal atresia. Its use is only intended for infants who do not have a tracheoesophageal fistula or who have had the fistula repaired in a prior surgery, according to an FDA news release.

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