Pediatric esophageal atresia is absence or abnormal narrowing of an opening in the body. It is a congenital defect of the esophagus that occurs in early stages of pregnancy while the baby is developing. The condition occurs due to malformation consisting of discontinuity between the upper and lower esophageal pouches. The defect is frequently associated with tracheoesophageal fistula. In tracheoesophageal fistula, babies have their esophagus abnormally attached with windpipe (trachea). In normal cases, during the early stages of fetal development, the esophagus and windpipe forms a hollow tube joining the mouth to stomach. However, in newborn babies with this congenital defect, the esophagus dose not grow to form a single hollow tube connecting the wind pipe, and instead two separate tubes are formed. The gap between these tubes can be short or very long. This defect needs to be corrected by surgical method to prevent fluids from the esophagus entering the windpipe of the infant causing breathing problems. At times, other birth defects may also co-exist, primarily in the heart and sometimes also in spinal column, anus, or kidneys. This condition is referred as VACTERL association due to possible involvement of vertebral column, anorectal, cardiac, tracheal, esophageal, renal, and limbs.
One half of the newborn babies having esophageal atresia have associated congenital anomalies. An estimated 1 in 25,000 babies in the U.S. is born with this defect. On May 12, 2017, the U.S. Food and Drug Administration approved the use of Flourish pediatric esophageal atresia device for treating infants with esophageal atresia. The device enables doctors to repair the esophagus in infants who were born with a defect in the esophagus without a surgery. However, the device is only used to treat infants who do not have a tracheoesophageal fistula or in whom the fistula has been repaired. The device uses a magnetic system to pull both the upper and lower esophagus for closure of the gap and enabling food to enter the stomach. During this procedure, doctors insert two catheters (flexible tubes), one from the oral cavity and one through the stomach of the patient. Due to the magnetic attraction between the ends of the two tubes, the esophagus is pulled together, thereby closing the gap, and hence forming a continuous connection from the esophagus to the stomach. The infant can be fed through the mouth after the catheters are removed. About 3 to 13 days are required for completion of the procedure. During this period the gap between the disconnected esophagi gets closed.
The global pediatric esophageal atresia device market is projected to witness strong growth due to increase in awareness about the defect and advancement in the field of science and technology. The device has received approval via Humanitarian Use Device (HUD) pathway. Cook Medical has received the FDA authorization for Flourish pediatric esophageal atresia device. However, some complications such as ulceration or irritation in tissue around the catheter and gastoesophageal reflux are likely to restrain the market. Moreover, high cost of the procedure is expected to restrain the global pediatric esophageal atresia device market.
The global pediatric esophageal atresia device market can be segmented based on end-user and region. In terms of end-user, the market can be divided into pediatric clinics, hospitals, and health care organizations. Studies have shown a high prevalence of this defect in Europe. Hence, there is a wide scope for this device in the region. The pediatric esophageal atresia device market in other parts of the world is expected to witness significant growth during the forecast period due to sporadic and stable prevalence of this birth defect.