New device approved for lingering GERD
New Device Approved for Lingering GERD
HealthDay News -- The FDA has approved the LINX Reflux Management System to treat people with gastroesophageal reflux disease (GERD) who continue to have chronic symptoms, despite taking maximum medication and making recommended lifestyle changes.
GERD occurs when stomach contents flow back into the esophagus, causing heartburn and potential damage to the esophagus. People with the condition are first advised to make changes such as losing weight, eating foods that are less likely to cause symptoms and eating smaller meals, the FDA said in a press release.
When these steps and medication do not completely relieve chronic symptoms, the newly approved device offers another option, the agency said. It's made up of a series of titanium beads with magnetic cores that are joined with titanium wire to form a circular shape. The device is implanted in the lower esophageal sphincter (LES), a circular-shaped muscle at the base of the esophagus that's designed to prevent the reverse flow of stomach contents. The magnetic beads are meant to reinforce the LES and keep it closed.
The approval was based on five-year follow-up results from a four-center feasibility study that involved 44 patients and a pivotal study that involved 100 patients at 14 centers, all of whom had GERD and chronic GERD symptoms despite receiving medical therapies. Study findings indicated that the benefits obtained with the LINX Reflux Management System outweigh its risks. The most common adverse reactions included swallowing problems, chest pain, vomiting and nausea.
As a condition of the approval, the FDA is requiring that patients treated with the device undergo a training program that will contain educational material about patient selection, device implantation and post-procedural care.
People who have device implanted will no longer be able to undergo magnetic resonance imaging, as the magnetic beads interfere with the machine and can cause the device to be damaged and the patient to be injured, the agency warned.
The device is produced by the St. Paul, Minn., based company, Torax Medical Inc.