The US Food and Drug Administration (FDA) recently approved a Flourish pediatric esophageal atresia stapler developed by medical device company Cook Medical, the first medical device approved by the FDA for infant esophageal atresia (EA) within one year of age. .
Esophageal atresia (EA) is a severe gastrointestinal malformation caused by continuous interruption of esophageal dysfunction. The child cannot eat normally. The feeding tube needs to be placed until surgery can be performed to connect the esophagus to the stomach. Most of the children are accompanied by tracheoesophageal fistula (TEF), and the corresponding clinical manifestations appear. Because the esophageal fluid enters the respiratory tract through the fistula and interferes with breathing, it is also necessary to repair the fistula. The incidence of esophageal atresia (EA) is about 1/2500~1/4000. It is a rare neonatal disease, but it is easy to be misdiagnosed. Untreated children often suffer from hunger, aspiration pneumonia, cough and suffocation. Serious complications, even death.
It is estimated that in the United States, one in 2,500 newborns has esophageal atresia (EA). Dr. William Maisel, Executive Director of the Equipment Evaluation Office of the FDA's Equipment and Radiation Health Center, said the approved Flourish equipment will provide clinicians in the United States with a non-surgical treatment option to treat infantile esophageal atresia (EA). However, it should be noted that the application of this device is limited to infants who have not had a tracheal esophageal fistula (TEF) or have had a fistula repair in the previous surgery.
The Flourish pediatric esophageal atresia stapler uses magnets to pull the upper esophagus and the lower esophagus together, closing the gap and allowing food to enter the stomach. During the implantation of the Flourish device, the doctor needs to insert 2 catheters at the same time, one through the mouth and one through the stomach. The magnetic ends of the two catheters are attracted to each other. This attraction pulls the two ends of the esophagus together for several days, closing the gap and forming a connection. Once the catheter is removed, the baby can begin feeding through the mouth. This device is not suitable for infants with esophageal tracheal fistula (TEF), which is an abnormal connection between the esophagus and the trachea.
The FDA reviewed the FlourishFlourish pediatric esophageal atresia stapler through the Humanitarian Device Exemption (HDE) procedure. According to the FDA, HDE devices are designed to treat or diagnose disease types that do not exceed 8,000 patients per year in the United States.
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