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.
More information
To learn more about
GERD, visit the U.S. National Library of Medicine.