New Device Approved for Esophageal Birth Defect
MONDAY, May 15, 2017 -- A new medical device has been approved by the U.S. Food and Drug Administration to treat esophageal atresia, a birth defect that causes a gap between the esophagus and stomach.
One of 2,500 babies in the United States is born with the condition, the agency said in a news release. These infants require a feeding tube until surgery is performed to connect the esophagus to the stomach.
Many babies born with the condition also develop a fistula (an abnormal connection between the esophagus and the trachea in this case) that may allow esophageal fluids to leak into the airways and interfere with breathing, the FDA said. This complication also requires corrective surgery.
"This new device provides a non-surgical option for doctors to treat esophageal atresia in babies born with this condition," said Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health. "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 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. However, 13 developed a complication that caused narrowing of the esophagus, medically called anastomotic stricture. This required surgery to repair, the FDA said. However, this complication is a frequent side effect of traditional surgery to repair the condition, the agency added.
The new device should not be used in infants older than a year, who have teeth, or whose esophageal segments are more than four centimeters apart, the agency warned.
Possible side effects of the device include stomach injury and gum irritation.
The FDA granted approval of the device to Cook Medical, based in Bloomington, Ind.
Learn more from the FDA.
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Posted: May 2017