Ethicon, part of the Johnson & Johnson Medical Devices Companies, stated its LINX Reflux Management System was shown to provide effective long-term control of gastroesophageal reflux disease (GERD). It also eliminated the need for daily reflux medications in 79% of patients in the longest-term study ever published on Magnetic Sphincter Augmentation (MSA).
The LINX Reflux Management System is a flexible ring of small magnets placed around the lower part of the esophagus, the body’s natural barrier to reflux, during a minimally invasive procedure. The magnetic ring expands when a person ingests food and then contracts to prevent stomach contents, including gastric acid, from backing up into the esophagus and causing GERD.
In the single-center (IRCCS Policlinico San Donato in Italy) retrospective study of 335 patients who had an MSA procedure with LINX between 2007 and 2020, 124 patients who had been implanted for at least 6 years and up to 12 (median 9 years) were followed. Nearly 90% of LINX patients experienced long-term favourable, outcomes defined as a greater than 50% improvement in their GERD-health related quality of life (GERD-HRQL) score and the discontinued use of proton pump inhibitors (PPIs), the current standard of care in medical therapy. There were no device erosions or migrations and only three instances (2.4%) of device removal due to either continued reflux symptoms, dysphagia or the need for an MRI in this long-term group. Patient satisfaction was 93.8% after 10 years.
Study Co-Author Luigi Bonavina, MD, Professor of Surgery at University of Milan School of Medicine and Chief of the Department of Surgery, IRCCS Policlinico San Donato said: “Our new study corroborates the findings of previous studies but over a longer period, which is important for an implanted device. The efficacy of the LINX System remained strong and the risk of complications did not increase many years after implantation. Based on these results and the high levels of patient satisfaction, MSA may represent a true paradigm shift that has the potential to fill the current therapy gap in GERD.”
Several GI and surgical societies, including the American Society of General Surgeons (ASGS), Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), the American College of Gastroenterology (ACG) and the American Foregut Society (AFS), have issued consensus statements in favour of LINX procedures for appropriate GERD patients.