New Device Approved for Lingering GERD
FRIDAY, March 23 (HealthDay News) -- The LINX Reflux Management System has been approved by the U.S. Food and Drug Administration 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 news release.
When these steps and medication don't completely relieve chronic symptoms, the newly approved device offers another option, the agency said. It's comprised 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 device was evaluated in a four-center study involving 44 people and five years of follow-up. The most common adverse reactions included swallowing problems, chest pain, vomiting and nausea.
People who have the device implanted should not have a magnetic resonance imaging (MRI) test, which involves the use of strong magnetic fields, the agency warned.
The device is produced by Torax Medical Inc., based in St. Paul, Minn.
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