FDA authorizes first medical device for esophageal atresia in infants

The FDA authorized the use of Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical device to treat infants up to 1 year old for the birth defect that causes a gap in their esophagus known as esophageal atresia.

“This new device provides a nonsurgical option for doctors to treat esophageal atresia in babies born with this condition,” William Maisel, MD, MPH, acting director, Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in a press release. “But it is only intended for infants who do not have a tracheoesophageal fistula or who have had the fistula repaired in a prior surgery.”

“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,” Barry Slowey, president and global business unit leader for Cook Medical’s Endoscopy business unit, the company that created the device, said in a press release.

According to the FDA and Cook Medical, Flourish Pediatric Esophageal Atresia Anastomosis is inserted into the body via a catheter through the mouth and another through the stomach. The magnetic ends of the two catheters attract each other, pulling 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 idea was to create a minimally invasive procedure that could possibly be an alternative to surgery in selective pediatric cases,” Mario Zaritzky, MD, a pediatric radiologist at the University of Chicago Medical Center who collaborated with Cook Medical on the device, said in a press release. “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 FDA stated that all 16 of the infants that used Flourish Pediatric Esophageal Atresia Anastomosis in a trial had a successful joining of their esophagus, with no remaining gap, within 3 to 10 days after receiving it. However, 13 of these patients developed a complication which caused an anastomotic stricture that required a balloon dilation procedure, a stent or both to repair. Anastomotic strictures also occur from traditional surgery to repair the condition.

According to the FDA, infants who have a tracheoesophageal fistula, an abnormal connection between the esophagus and the trachea, patients older than one year, or who have teeth, should not use the device. In addition, Flourish Pediatric Esophageal Atresia Anastomosis is also contraindicated in infants who have an existing tracheoesophageal fistula or who have esophageal segments that are more than 4 cm apart.

The FDA also warned that possible complications after the device is implanted include tissue irritation or ulceration around the catheter in the stomach and gum irritation due to pressure from the catheter in the mouth. Possible long-term complications include gastroesophageal reflux.

An estimated one in every 2,500 babies in the U.S. is born with esophageal atresia, according to the FDA.

Disclosure: Healio Family Medicine was unable to confirm relevant financial disclosures prior to publication.

Editor’s Note: This story has been updated from an earlier version to include quotes from Cook Medical.