Cook Medical wins humanitarian nod from FDA for Flourish pediatric esophageal atresia device

Cook Medical (Bloomington, Ind.) recently received authorization from the FDA under the Humanitarian Device Exemption for a pediatric esophageal atresia treatment device called the Flourish. The device is now available in the U.S.

Esophageal atresia is a birth defect in the esophagus where the upper esophagus doesn’t connect to the lower part of the esophagus and the stomach, which means they are unable to eat normally. The condition affects 1 in 2,500 newborns.

Cook Medical’s Flourish Pediatric Esophageal Atresia device uses earth magnets that are inserted in the upper and lower ends of the infant’s esophagus. After several days, the magnets will gradually stretch both ends of the esophagus and the tissue will start to connect to form an intact esophagus.

The Humanitarian Use Device designation is reserved for the treatment or diagnosis of a disease or condition that affects fewer than 8,000 individuals in the U.S. per year.

“We’re thrilled to be able to officially offer this minimally invasive approach for infants suffering with the condition to physicians in the U.S.,” Barry Slowey, president of Cook Winston-Salem and VP of Cook Medical’s endoscopy specialty, said in a press release. “It has been especially rewarding to see the positive effects that Flourish has had on these children. An important part of our culture is to support patient populations that don’t have access to treatment options, which is why we worked with the FDA to establish the HDE pathway.”