FDA Clears First-of-Its-Kind Device for Esophageal Atresia

Megan Brooks

Disclosures

May 12, 2017

The US Food and Drug Administration (FDA) approved a first-of-its-kind medical device to treat esophageal atresia, a birth defect that causes a gap in the esophagus.

The Flourish Pediatric Esophageal Atresia Anastomosis from Cook Medical uses magnets to pull the upper and lower esophagus together, closing the gap and allowing food to enter the stomach. The device is for use in infants up to 1 year old.

"This new device provides a nonsurgical 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 news release.

Esophageal atresia affects an estimated 1 of every 2500 babies born in the United States, the agency notes. Babies with this condition cannot feed normally, and they require a feeding tube until surgery can be performed to attach the esophagus to the stomach.

The procedure to insert the Flourish device involves inserting two catheters, one through the mouth and one through the stomach. The magnetic ends of the two catheters attract each other, and this attraction pulls 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 FDA cleared the Flourish device through its humanitarian device exemption pathway. Devices can be designated a humanitarian device if they treat or diagnose a disease or condition affecting fewer than 8000 individuals in the United States each year.

Data supporting the safety and probable benefit of the Flourish device include results from 16 patients for whom the Flourish device had been implanted. Joining of the esophagus was successful in all of the infants, with no remaining gap, within 3 to 10 days after receiving the device, the FDA said. However, 13 of the 16 patients developed anastomotic stricture that required a balloon dilation procedure, a stent, or both to repair.

The Flourish device should not be used in patients older than 1 year or in those who have teeth, which may damage the oral catheter. The device is also contraindicated in infants who have an existing tracheoesophageal fistula or who have esophageal segments that are more than 4 cm apart.

Potential complications that may occur when the device is in place include ulceration or tissue irritation around the catheter implanted in the stomach and gum irritation due to pressure from the oral catheter. Potential long-term complications include gastroesophageal reflux.

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