Gastroesophageal reflux disease is caused by gastric contents which reflux into the esophagus. Magnetic sphincter augmentation(MSA) can increase the tension of the lower esophageal sphincter (LES) to achieve anti-reflux effect. The study uses the MSA produced by Ningbo Senscure Biotechnology Co., Ltd., and verify the safety and effectiveness of this operation.

MSA device was implanted into the lower esophageal sphincter of 12 experimental animals (pigs) under surgical or laparoscopy. The changes of dietary behavior and body weight were observed for 1 month, 3 months and 6 months respectively.Changes of LES pressure and barium radiography which was used to observe feeding patency, expansion and closure of MSA were also measured and performed. The experimental animals were dissected, and observed whether there were displacement or corrosion of MSA, esophageal obstruction, esophageal inflammation, erosion and necrosis of the animals.

The experimental animals were able to eat normally, 3 cases of occasional vomiting, 3 cases of vomiting when eating fast, 3 cases with increased body weight. Barium radiography showed no significant proximal esophageal dilation and other factors that hinder swallowing.The average LES pressure after operation had a significant increase (P<005). The mucosa of the esophagus appeared normal in all cases, and there was no device migration. There was no significant tissue inflammation for 10 cases, and 2 cases were observed to have inflammatory cell infiltration under microscope.

MSA can be easily implanted via laparotomy or laparoscopy. This study shows that the device and the mounting technique are safe and reliable, which can be applied to patients with gastroesophageal reflux disease.