Written by: Sarah Assali & Nova Szoka MD
Wilson-Cook Medical Inc. received FDA approval for the Flourishâ„¢ Pediatric Esophageal Atresia Device on May 12, 2017.
This product is intended for the non-surgical correction of esophageal atresia less than 4 centimeters apart in children up to 1 year of age. It utilizes 2 catheters with magnets on one end of each. One catheter is inserted through the mouth and the other is inserted through a gastrostomy site. The magnets then approximate the 2 blind ends of the upper and lower esophagus. Once both ends are approximated, the surrounding tissues begin to grow together and the tissue between the 2 magnets erodes, creating an anastomosis over the course of 3-13 days.
There is limited data to support its use. Results from 16 patients who were treated with this device all showed successful joining of the 2 ends of their esophagus within 3-10 days of device implantation. However, 13 of the 16 patients developed an anastomotic stricture of the esophagus requiring balloon dilation, stenting, or both.
The FDA has not determined this device to be substantially equivalent to predicate devices.
Indications:
- Pediatric patients, up to one year of age, with esophageal atresia without a tracheoesophageal fistula (TEF) or for whom a TEF has been closed as a result of a prior procedure. This device should be used only when the gap between the upper and lower portions of the esophagus is less than 4 centimeters apart.
Contraindications:
- Existing tracheoesophageal fistula
- Age older than 1 year
- Have teeth
- Gap of 4 centimeters or more between the upper and lower esophagus
- Have atresia that needs treatment in a part of the body other than esophagus
- Do not have established and appropriately sized gastrostomy tract
- Have signs of significant infection at the gastrostomy site
