Now there is a new operation, which can cure reflux esophagitis. Just search LINX anti-reflux system on the Internet. A minimally invasive surgery can solve the reflux problem. This reflux management instrument named LINX is made by Torax, Minnesota, USA. Medical,? Manufactured by Inc.
On January 11th, 212, the Gastroenterology and Urology Equipment Advisory Group of the US Food and Drug Administration (FDA) voted on the pre-marketing license of LINX anti-reflux system. Nine members of the group voted unanimously to affirm the efficacy, safety and favorable risk-benefit ratio of the device against pathological gastroesophageal reflux disease (GERD) which is refractory to reflux drugs. The anti-reflux system is composed of a series of magnetic beads, and the attraction between the beads can help lower esophageal sphincter (LES) to close, thus playing an anti-reflux role. When the patient swallows, food can also spread the bead string into the stomach.
■? Clinical problems in controlling symptoms of gastroesophageal reflux:? PPI, surgery or something else? GERD is one of the most prevalent gastrointestinal diseases in the United States. In addition to painful symptoms, GERD can lead to esophageal mucosal injury, Barrett's esophagus, and can also develop into adenocarcinoma. At present, the main medical treatment is taking proton pump inhibitor (PPI) every day. PPI is very effective for esophagitis, but it is not effective for controlling reflux symptoms. Although fundoplication can effectively rebuild the barrier against reflux, it permanently changes the anatomical structure of the stomach and will produce many side effects. Over the years, people have been exploring new technologies, hoping to enhance the strength of LES and avoid the adverse consequences of fundoplication. These techniques include suturing the relaxed lower esophageal sphincter and injecting polymers to change LES compliance. Unfortunately, few of them have been approved by the FDA. In this case, LINX anti-reflux system came into being, and doctors can place it above the patient's stomach and near the lower esophageal sphincter through laparoscopy. Because of the short operation time, the patient can resume normal diet and activities within one week, and can be taken out by laparoscopy, this technique attracts people's attention. ■? The FDA Advisory Group suggested that there were "hard wounds" in clinical trials, but the defects did not cover up. The feasibility study of LINX system * * * included 44 patients from four research institutions in Europe and America. One and two years after operation, 85% and 9% of patients reported improvement in symptoms, respectively. 9% and 86% patients reported stopping using PPI completely. 43% of the patients had dysphagia in the early stage, and most of them disappeared within 9 days after operation. One patient was taken out of the anti-reflux system by laparoscopy because of persistent dysphagia. The key study included 1 patients from 14 research institutions. After operation, 92% of patients reported improvement of symptoms, 93% of patients had at least half of PPI dosage, and 64% of patients had normal or improved esophageal acid exposure. The incidence of serious adverse events was 6%: 3 patients had to take out the anti-reflux system because of dysphagia; Two patients were hospitalized again for nausea and vomiting 7 days after operation. One patient was admitted to hospital with chest pain 6 months after operation, and the system was taken out 1 year after operation. The FDA advisory group's debate about safety focuses on dysphagia. 68% patients with anti-reflux system reported dysphagia, which was the most frequently reported complication. The team's knowledge is that dysphagia symptoms are relatively mild, not a safety hazard. Dr Gould of Milwaukee Medical College in Wisconsin believes that if we study the Nissen fundoplication cohort, there will also be some symptoms that are not common with other treatments, so we should look at its safety as a whole. Dr. Schwaitzberg of Harvard Medical School thinks that there is a "hard injury" in the relevant clinical research design, but he also thinks that "their demonstration of its efficacy and low complication rate is quite good". Schwartzberg stressed: "I hope to see the research lasting at least 1 years after approval. As an implantable medical device, we should understand the long-term results." Team statistician, Dr. Afifi of UCLA, said he would like to see a case-control study. Dr. Faulx of case western reserve university Medical Center in Ohio commented that compared with the less perfect current standard treatment, the LINX anti-reflux system has proved to be quite useful and the risk is minimal.