FDA approves medical device to treat esophageal atresia
The FDA has approved a device that uses magnetic catheters to draw the upper and lower esophagus together.
(HealthDay News) — A new medical device has been approved by the US Food and Drug Administration to treat esophageal atresia.
The Flourish Pediatric Esophageal Atresia Anastomosis device uses magnetic catheters to draw the upper and lower esophagus together, closing the gap and reliably allowing food to move into the stomach. In a study of 16 infants who used the device, all had a successful joining of the esophagus. Thirteen developed an anastomotic stricture.
The device should not be used in infants older than a year, who have teeth, or whose esophageal segments are more than 4 centimeters apart, the agency warned. Potential complications of placement of the device include stomach injury and gum irritation, and potential long-term complications include gastroesophageal reflux.
"This new device provides a non-surgical option for doctors to treat esophageal atresia in babies born with this condition," William Maisel, MD, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in a statement. "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."
The FDA granted approval of the device to Cook Medical, based in Bloomington, Indiana.
- US Food and Drug Administration. FDA authorizes use of new device to treat esophageal birth defect in babies [press release]. Published May 12, 2017. Accessed May 31, 2017.