The FDA is now allowing the introduction of Cook Medical‘s Flourish Pediatric Esophageal Atresia Anastomosis device as a non-surgical option for treatment of esophageal atresia, a birth defect in which the esophagus is not connected to the stomach due to a poorly formed esophagus.
Two catheters with magnetic tips are positioned at the ends of the disconnected esophagus, one delivered transorally and the other via a gastric catheter through the stomach. The magnetic tips pull at each other and eventually push through the tissue to have the catheters meet each other. The child’s natural ability to heal allows this to happen within a couple weeks, and hopefully for the esophagus to develop normally.
In a small study of the Flourish device, it successfully restored the esophageal lumen in all the infants, though most had to receive subsequent balloon dilation, stenting, or both.
The Flourish device should not be used 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 complications that may occur when the device is in place include ulceration or tissue irritation around the catheter implanted in the stomach and gum irritation due to pressure from the oral catheter.
Potential long-term complications include gastroesophageal reflux.
Link: FDA’s overview of Flourish…
Via: FDA…
Your information will never be shared with any third party.