News from the FDA/CDC

New device that treats esophageal atresia in infants has been authorized

 

Key clinical point: The Flourish device will treat esophageal atresia in newborns.

Major finding: All of the 16 patients implanted with the Flourish device were successfully treated for esophageal atresia.

Data source: Data was provided by Cook Medical under a humanitarian device exemption. A total of 16 patients were implanted with the Flourish device.

Disclosures: This study was sponsored by Cook Medical.


 

The FDA has authorized a medical device to treat infants up to age 1 year for esophageal atresia, called the Flourish Pediatric Esophageal Atresia Anastomosis.

The device uses magnets attached to two catheters to pull the upper and lower esophagus together, closing the gap for several days until a connection is formed. The catheters are then removed, and the infant can begin feeding via mouth.

“This new device provides a nonsurgical option for doctors to treat esophageal atresia in babies born with this condition,” said William Maisel, MD, MPH, acting director of the FDA’s Office of Device Evaluation. “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.”

Cook Medical provided data on 16 patients implanted with Flourish devices. All patients had successful joining of their esophagus within 3-10 days after receiving the device. A total of 13 of the 16 patients developed anastomotic stricture that required a balloon dilation procedure, a stent, or both to repair. Such strictures also occur with traditional surgery.

The Flourish device should not be used in patients older than 1 year. Other potential complications that may occur include stomach or mouth irritation near the catheter insertion sites and gastroesophageal reflux.

Learn more about the study at www.fda.gov/newsevents/newsroom/pressannouncements/ucm558241.htm.

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