The US Food and Drug Administration (FDA) has authorised the use of Cook Medical’s Flourish Pediatric Esophageal Atresia Anastomosis device for the treatment of esophageal atresia in infants up to one year old.
Esophageal atresia is a birth defect observed in babies and is characterised by a gap in the esophagus.
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The Flourish device closes the gap by using magnets to pull the upper and lower esophagus together.
During the procedure, two catheters are inserted separately through the mouth and the stomach.
The magnetic ends of these catheters attract each other, pulling the ends of the esophagus together, over several days.
The infant can be fed through the mouth, following the removal of the catheters.
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By GlobalDataThe device cannot be used in infants with tracheoesophageal fistula, which is an abnormal connection between the esophagus and the windpipe (trachea).
FDA Centre for Devices and Radiological Health Device Evaluation office acting director William Maisel said: “This new device 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 do not have a tracheoesophageal fistula or who have had the fistula repaired in a prior surgery.”
The FDA authorisation is based on the safety data obtained from the evaluation of the Flourish device in 16 patients.
While joining of their esophagus was observed within three to ten days, with no gap, 13 of the 16 infants developed a complication that required a balloon dilation procedure and/or a stent for repair.
