LINX Device Long-term Safety in Reflux Disease

This study, sponsored by Ethicon Endo-Surgery, Inc., focuses on the long-term safety of the LINX Reflux Management System, a device used to treat reflux disease. It involves a registry called the RETHINK REFLUX Registry, which monitors patients who have received the LINX device. Up to 500 participants will be involved, with the study taking place in various centers across the United States and other approved countries. This research is crucial as it seeks to confirm the safety of using the LINX device over a long period, ensuring that it is a reliable option for managing reflux disease. Additionally, the study will explore the device's effectiveness and its impact on healthcare costs and usage. Participants in the study will have the LINX device implanted, and their progress will be observed over a span of 10 years. The study will primarily focus on any adverse events that may occur due to the device or the implantation procedure, such as difficulty swallowing, pain during swallowing, device movement, or erosion. It will also track instances where the device needs to be removed and the recurrence of hiatal hernias after device implantation. By gathering data on these outcomes, the study aims to provide comprehensive insights into the long-term safety and effectiveness of the LINX system.