Cook Medical has launched the Flourish pediatric esophageal atresia device. In the US,
Flourish device secured the authorization from the US Food and Drug Administration (FDA) under the humanitarian device exemption (HDE) to treat pediatric esophageal atresia.
Esophageal atresia is a birth defect of the esophagus where the upper part of the esophagus will not be connected to the lower part of the esophagus and the stomach in babies born with this defect.
The Flourish device uses rare earth magnets, which are inserted into the upper and lower ends of the infant’s esophagus. The magnets gradually stretch both ends of the esophagus over the course of several days. Later, the tissue connects to form an intact esophagus.
According to the company, the esophageal atresia affects around 1 in 2,500 newborns and humanitarian use device (HUD) designations are reserved to treat or diagnose a disease or condition that affects fewer than 8,000 individuals in the US per year.