FDA Signs Off on New Device to Treat Esophageal Birth Defect in Babies

Posted 12 May 2017 By Zachary Brennan

placeholder+image

The US Food and Drug Administration (FDA) on Friday authorized the use of a first-of-its-kind medical device to treat infants up to one year old for a rare birth defect that causes a gap in the esophagus.

The device, Cook Medical’s Flourish Pediatric Esophageal Atresia Anastomosis, was authorized via the humanitarian device exemption (HDE) process as an estimated 1 in every 2,500 babies in the US is born with the condition, known as esophageal atresia.

"This new device provides a non-surgical option for doctors to treat esophageal atresia in babies born with this condition," said William Maisel, MD, acting director of the Office of Device Evaluation in 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."

How the device works: Doctors insert 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 that, once the catheters are removed, allows the infant to feed by mouth.

The device was authorized based on data from 16 patients who had the Flourish device implanted. FDA notes, “In the limited data provided, all of the infants had a successful joining of their esophagus, with no remaining gap, within three to 10 days after receiving the device.  However, 13 of the 16 patients developed a complication which caused a narrowing in their esophagus (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.”

Flourish Pediatric Esophageal Atresia Device - H150003

Share this article:

Categories: Medical Devices, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, CDRH

Tags: humanitarian device exemption, FDA device approvals

Regulatory Exchange: Latest Updates From the Community