This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Probable Benefit (SSPB) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Flourish™ Pediatric Esophageal Atresia Device
HDE Applicant: Wilson-Cook Medical Inc.
Address: 4900 Bethania Station Road, Winston-Salem, NC 27105
Approval Date: May 12, 2017
Approval Letter: Not Yet Available
What is it? The 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). These patients are unable to eat by mouth.
How does it work? 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. Within 3-13 days, the tissue trapped between the magnets will die and a hole (anastomosis) will open between the two portions of the esophagus.
When is it used? The Flourish Pediatric Esophageal Atresia Device is indicated for use in 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.
What will it accomplish? Limited clinical data has demonstrated that the device is able to connect the upper and lower portions of the esophagus and restore the function of the upper digestive tract.
When should it not be used? 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.
Additional information (including warnings, precautions and adverse events):
- Esophageal atresia: MedlinePlus Medical Encyclopedia
- FDA News Release: FDA authorizes use of new device to treat esophageal birth defect in babies
Summary of Safety and Probable Benefit and labeling will be available online. (Not Yet Available)