New data shows benefits of Linx Reflux System (Torax Medical Inc) for patients with GERD
A new study provides evidence of safety and effectiveness for the Linx Reflux Management System, from Torax Medical Inc, for the treatment of patients with GERD. This prospective, multicenter trial is part of the FDA pre-market approval process. The patients were evaluated before and after treatment to determine the effect of the Linx System on their GERD using pre-defined success criteria, which included reduction of oesophageal acid, improvement in quality of life and elimination of reflux medications.
After sphincter augmentation with the Linx System, the majority of patients were able to substantially reduce or resolve their reflux symptoms, while eliminating use of their reflux medications. Severe regurgitation was eliminated in 100% of patients, and nearly all patients (93%) reported a significant decrease in the need for medication. More than 9 in 10 patients (94%) reported satisfaction with their overall condition after having the Linx System, compared to 13% before treatment while taking medication. Results were published in the New England Journal of Medicine. See: "Esophageal Sphincter Device for Gastroesophageal Reflux Disease." Robert A. Ganz et al. N Engl J Med 2013; 368:719-727February 21, 2013DOI: 10.1056/NEJMoa1205544