Cook Medical won FDA approval for its Flourish pediatric esophageal atresia anastomosis device, which is designed to treat infants with a birth defect that causes a gap in the esophagus.
Babies born with esophageal atresia cannot feed normally and need a feeding tube until surgery is performed to attach the esophagus to the stomach.
The device, which is the 1st of its kind, uses magnets to pull the upper and lower esophagus together, closing the gap. It is not indicated for use in infants who have an abnormal connection between the esophagus and windpipe, also known as a tracheoesophageal fistula.
“This new device provides a non-surgical option for doctors to treat esophageal atresia in babies born with this condition,” Dr. William Maisel said in prepared remarks. Maisel is the acting director of the office of device evaluation in the FDA’s Center for Devices and Radiological Health.
To implant the Flourish device, doctors insert a catheter into the mouth and another through the stomach. The magnetic ends of the catheters attract each other, pulling the ends of the esophagus together over the course of several days. The infant can feed by mouth once the catheters are removed.
In support of the device’s approval, the FDA reviewed data from 16 patients through the humanitarian device exemption process. In this small group of patients, all of the infants experienced successful joining of the esophagus within 3 to 10 days following implantation.
However, 13 patients developed a complication that narrowed their esophagus and required treatment with a balloon dilation procedure or stent, according to the federal watchdog.
The FDA warned that the Flourish device is not to be used in patients older than 1 year or babies who have teeth. It is also contraindicated in infants with esophageal segments that are more than 4 centimeters apart.