FDA authorizes Flourish Pediatric Esophageal Atresia Anastomosis to treat esophageal atresia

FDA announced the authorization of Flourish Pediatric Esophageal Atresia Anastomosis to treat esophageal atresia in Infants.

Flourish Pediatric Esophageal Atresia Anastomosis is a first medical device to be used for the treatment. Babies with this condition cannot feed normally, and they require a feeding tube until surgery can be performed to attach the esophagus to the stomach. The device uses magnets to pull the upper and lower esophagus together, closing the gap and allowing food to enter the stomach. It is not for use in infants who also have a tracheoesophageal fistula, an abnormal connection between the esophagus and the windpipe (trachea).

During the procedure to insert the Flourish device, doctors insert two catheters, one through the mouth and one through the stomach. The magnetic ends of the two catheters attract each other, and this attraction pulls the two ends of the esophagus together over several days, closing the gap and forming a connection. Once the catheters are removed, the infant can begin to feed by mouth.

The Flourish device should not be used in patients older than one year, or who have teeth, which may damage the oral catheter. The device is also contraindicated in infants who have an existing tracheoesophageal fistula or who have esophageal segments that are more than 4 centimeters apart. Potential complications that may occur when the device is in place include ulceration or tissue irritation around the catheter implanted in the stomach and gum irritation due to pressure from the oral catheter. Potential long-term complications include gastroesophageal reflux.

The FDA reviewed data for the Flourish device through the humanitarian device exemption (HDE) process. A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects not more than 8,000 individuals in the U.S. per year.