The first-of-its-kind device for the treatment of esophageal atresia approved by FDA

Esophageal atresia is a birth defect or congenital medical condition; it has an effect on the alimentary tract. It results in the ending of the esophagus instead of normally linking to the stomach. According to a survey, a projected 1 in 2500 babies in the United States is born with the ailment.

The babies suffering from esophageal atresia need a feeding tube till the surgery can connect the esophagus to their stomach. A majority of babies born with the disorder also have a tracheoesophageal fistula, which should also be rectified surgically, as the liquids from the esophagus can enter the airways and hinder breathing.

Recently, the Food and Drug Administration (FDA) granted approval for using the flourish pediatric esophageal atresia anastomosis by Cook Medical. The medical device is intended for the treatment of babies with esophageal atresia up to 1-year old. The data was reviewed by the FDA via the humanitarian device exemption procedure.

William Maisel said, “This new tool offers a non-surgical alternative for doctors to tackle the esophageal atresia in children born with this defect. But it is only proposed for a toddler who is not having a tracheoesophageal fistula or who had a previous surgery for repairing the fistula.”

The new system utilizes magnets to drag the lower and upper esophagus together, sealing the space created due to esophageal atresia and thus permits the entry of the food into the stomach. During the insertion procedure of the device, the doctors introduce one catheter via stomach and other via the mouth. The magnetic ends of the 2 catheters attract each other, dragging the 2 ends of the esophagus together over numerous days, which shuts the gap and creates a connection. After the catheters are detached, the child can start to feed by mouth.

The flourish device is not intended for the treatment of patient older than a year, or babies with teeth as this can destruct the oral catheter. The possible complications consist of tissue irritation or ulceration around the implanted catheter in the stomach, and gum irritation owing to strain from the oral catheter. The probable long-term effects included gastroesophageal reflux.