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Cook Medical Gets FDA OK for Device to Treat Rare Birth Defect

Xconomy Indiana — 

In rare instances, a baby’s esophagus develops improperly during pregnancy, leaving a gap in this tube connecting the throat to the stomach. Babies born with this condition can’t eat by mouth, and they require surgery to repair the defect.

Bloomington, IN-based Cook Medical recently received FDA approval for a new medical device that offers a non-surgical way to treat this defect—called pediatric esophageal atresia—though most babies treated with the device still required an additional repair procedure, as they sometimes do after surgery. While Cook’s Flourish device can’t treat all babies born with this condition, Mario Zaritzky, a pediatric radiologist at the University of Chicago Medical Center and a paid consultant to Cook, says the device gives surgeons another option.

“The idea was to create a minimally invasive procedure that could possibly be an alternative to surgery in selective pediatric cases,” Zaritzky said in a prepared statement.

The Cook device, which was developed at the company’s endoscopy division in Winston-Salem, NC, employs two catheters, each with a magnet on its tip. One catheter is inserted through the mouth; the other through the stomach. The magnetic tips attract each other and gradually pull the disconnected ends of the esophagus together, the FDA says. Over the course of several days, the gap in the esophagus closes. In less than two weeks, the tissue trapped between the magnets dies, leaving a hole through which food and liquids can pass through the connected esophagus.

An estimated one in 2,500 babies in the U.S. is born with esophageal atresia, according to the FDA. In some of these babies, the esophagus develops a connection to the windpipe, which is called a tracheosophageal fistula. This abnormality can cause breathing problems due to fluid from the esophagus getting into the airway, the FDA says.

The Cook product is classified as a humanitarian use device, a designation reserved for treating or diagnosing conditions that affect fewer than 8,000 people in the U.S. each year. As a humanitarian device, Cook was exempt from requirements to demonstrate the device’s efficacy through clinical trials. But the humanitarian device exemption still required Cook to show that its device poses no significant risk of injury.

Cook supported its application with data from 16 patients treated with its device. While the device successfully closed the esophageal gap in all of them, the FDA says 13 of those patients developed a narrowing in the esophagus that required an additional procedure to repair. The FDA notes that this narrowing can also develop following the surgery that has been the traditional approach to correcting esophageal atresia.

Approval of the Cook device is limited to patients age 1 or younger. The device can’t be used if the gap between the two disconnected ends of the esophagus is larger than 4 cm. The device is also not approved for use in infants whose defect includes a tracheosophageal fistula.

The FDA says potential complications from treatment with the Cook device include irritation where the catheter is implanted in the stomach and gum irritation from the catheter inserted through the mouth. Potential long-term complications include gastroesophageal reflux, the flow of stomach acid back into the esophagus.

Diagram by Cook Medical.