First-of-its-Kind Device Cleared to Treat Esophageal Birth Defect
The Food and Drug Administration (FDA) has granted authorization for Flourish Pediatric Esophageal Atresia Anastomosis (Cook Medical), a medical device to treat infants up to age 1 for esophageal atresia.
Esophageal atresia is a birth defect where babies cannot feed normally and require a feeding tube until surgery is done to attach the esophagus to the stomach. This first-of-its-kind medical device is a new non-surgical option for babies born with this condition. It works by using magnets to pull the upper and lower esophagus together, closing the gap to allow food to enter the stomach.
The device, however, is not intended for use in infants who also have a tracheoesophageal fistula, an abnormal connection between the trachea and the esophagus. Also, it should not be used in those aged >1 year or those who have teeth, as it may damage the oral catheter.
When inserting the Flourish device, a catheter is inserted through the mouth and another catheter through the stomach. The magnetic attraction at the ends of both catheters allow the gap to close and form a connection. The infant can then begin to feed by mouth once the catheters are removed.
The FDA approval was supported by data from 16 patients who were implanted with the Flourish device. All of the infants demonstrated a successful joining of their esophagus within 3–10 days after receiving the device. Thirteen of 16 infants, however, developed a complication causing an anastomotic stricture that required a balloon dilation procedure, a stent or both; this complication can also occur with traditional surgery. Other potential complications include ulceration or tissue irritation around the catheter implanted in the stomach, as well as gum irritation from the pressure of the oral catheter; gastroesophageal reflux is a potential long-term consequence.
For more information visit FDA.gov.