“Flourish Pediatric Esophageal Atresia Anastomosis” authorized by FDA to Treat Esophageal Atresia

Finally the Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical device to treat infants up to one year old for a birth defect that causes a gap in their esophagus, called esophageal Atresia is authorized to use by FDA.

In the U.S, estimated 1 out of 2,500 babies is born with esophageal atresia. To feed babies with this condition requires a feeding tube until the surgery. Surgery performed to attach the esophagus to the stomach. Most of the estophageal atresia affected babies also suffered from tracheoesophageal fistula, which also required surgery to aid this, since fluids from the esophagus can get into the airways and interfere with breathing.

William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health told media that Pediatric Esophageal Atresia Anastomosis, provides a non-surgical option for doctors to treat esophageal atresia in babies born with this condition, but it is only intended for infants who don’t have a tracheoesophageal fistula or who have had the fistula repaired in a prior surgery.

This device makes use of the magnets to pull the upper and lower esophagus together, filling the gap and enabling food to enter the stomach. This device can’t be use for infants who also suffered from tracheoesophageal fistula, an abnormal connection between the esophagus and the windpipe (trachea).

To insert the Flourish device, doctors follows the specific procedure. They insert two catheters, one through the mouth and one through the stomach. The magnetic ends of the two catheters attract each other, and this magnetic effect pulls the two ends of the esophagus together over several days, filling the gap and forming a connection.  After that catheters are removed and the infant begins to feed by mouth.

After reviewing the data through humanitarian device exemption (HDE) process, FDA found this is very useful to treat infants. A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects not more than 8,000 individuals in the U.S. per year.

There are some limitations for the use of the Floursih device. You can’t use it in patients older than one year, or who have teeth, which may damage the oral catheter. The device is also contraindicated in infants who have an existing tracheoesophageal fistula or who have esophageal segments that are more than 4 centimeters apart. Potential long-term complications include gastroesophageal reflux.

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