Cook Medical announced today that the U.S. Food and Drug Administration (FDA) has granted the Flourish™ Pediatric Esophageal Atresia device authorization 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 connecting the mouth to the stomach, in which the upper portion of the esophagus does not connect to the lower portion of the esophagus and stomach. Surgery has traditionally been the only treatment option to repair the malformation until Dr. Mario Zaritzky, a pediatric radiologist at the University of Chicago Medical Center, and Cook collaborated on the development of a minimally invasive, magnet-based approach.
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. To date, 16 patients have been successfully treated with this device.