Flourish™ Pediatric Esophageal Atresia device authorization under the Humanitarian Device Exemption (HDE) for the treatment of pediatric esophageal atresia
Cook Medical today announced 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.1
“The idea was to create a minimally invasive procedure that could possibly be an alternative to surgery in selective pediatric cases,” said Dr. Zaritzky. “Any procedure that can potentially replace major thoracic surgery with a less invasive method should be considered before deciding to go to the operating room.”
The Flourish Pediatric Esophageal Atresia Device received a Humanitarian Use Device (HUD) designation and was reviewed through the HDE pathway. A HUD treats or diagnoses a disease or condition affecting fewer than 4,000 individuals in the United States per year. In order to receive this type of authorization, a company must demonstrate, among other things, safety and probable benefit, i.e., that the device will not expose patients to an unreasonable or significant risk of illness or injury, and that the probable benefit of the device outweighs the risk of illness or injury. In addition there can be no legally-marketed comparable devices, other than another HDE, available to treat or diagnose the disease or condition.
“We’re very excited that FDA has acknowledged the importance of Flourish as a minimally invasive alternative for pediatric patients with esophageal atresia,” said Barry Slowey, president and global business unit leader for Cook Medical’s Endoscopy business unit. “This technology has the ability to provide a different approach to treatment for those infants who suffer from this condition, as well as for their parents and families.”