US-based Cook Medical’s Flourish™ Pediatric Esophageal Atresia Device is used to non-surgically repair the esophagus in infants who were born with their upper esophagus disconnected from their lower esophagus and stomach (esophageal atresia).
This device treats infants up to one year old for a birth defect.
The Flourish™ Device consists of two tubes (catheters), each of which contains a magnet at its tip. One tube is inserted through the mouth and the other through the stomach.
Once in place, the magnetic ends of the catheters attract one another and pull the ends of the esophagus together. Over several days, the gap between the upper and lower esophagus is closed and the surrounding tissue grows together.
The tissue trapped between the magnets will die and a hole (anastomosis) will open between the two portions of the esophagus, within 3-13 days.
This device should be used only when the gap between the upper and lower portions of the esophagus is less than 4 centimeters apart.
The device will be capable to connect the upper and lower portions of the esophagus and restore the function of the upper digestive tract.
This device should not be used to treat patients who:
• are older than one year of age,
• have an existing TEF,
• have teeth because these may damage the oral catheter,
• have a gap of 4 centimeters or more between their upper and lower esophagus,
• have atresia that needs treatment in a part of the body other than the esophagus,
• do not have an established and appropriately sized gastrostomy tract or
• have signs of significant infection at the gastrostomy site.