Cook Medical’s Flourish is Now Available

Cook Medical announced the availability of the Flourish Pediatric Esophageal Atresia device in the U.S. The device was granted authorization by the U.S. Food and Drug Administration (FDA) under the Humanitarian Device Exemption (HDE) for the treatment of pediatric esophageal atresia. Esophageal atresia is a birth defect of the esophagus – the tubular structure that connects the mouth to the stomach. In babies born with this condition, the upper part of the esophagus does not connect to the lower part of the esophagus and the stomach, making it impossible for them to eat normally. The Flourish Pediatric Esophageal Atresia device uses rare earth magnets that are inserted into the upper and lower ends of the infant’s esophagus. Over the course of several days, the magnets gradually stretch both ends of the esophagus, after which the tissue connects to form an intact esophagus. Previously, this condition could only be repaired surgically, but now doctors have another option.

In order to treat pediatric patients affected by this rare disorder, Flourish received approval from the FDA in 2017. Esophageal atresia affects around 1 in 2500 newborns. Humanitarian Use Device (HUD) designations are reserved for the treatment or diagnosis of a disease or condition that affects fewer than 8000 individuals in the United States per year. Between the time that FDA granted HUD designation in 2010 and approved the Humanitarian Device Exemption (HDE) for Flourish in 2017, 16 babies were successfully treated. “We’re thrilled to be able to officially offer this minimally invasive approach for infants suffering with this condition to physicians in the U.S.,” said Barry Slowey, president of Cook Winston-Salem and vice president of Cook Medical’s Endoscopy specialty. “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.” – Medical Buyer Bureau