Cook Medical on May 16 received clearance from the Food and Drug Administration for its Flourish Pediatric Esophageal Atresia device.
The device is intended to treat infants with esophageal atresia, a birth defect where the upper esophagus does not connect to the lower half of the esophagus and stomach.
Using the device, clinicians insert magnets into the upper and lower ends of the infant's esophagus to gradually stretch both ends and stimulate tissue to connect, forming an intact esophagus.
"The idea was to create a minimally invasive procedure that could possibly be an alternative to surgery in selective pediatric cases,” said Mario Zaritzky, MD, a pediatric radiologist at the University of Chicago Medical Center who collaborated with Cook Medical to develop the device. "Any procedure that can potentially replace major thoracic surgery with a less invasive method should be considered before deciding to go to the operating room."
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