Health Problem: Gastroesophageal reflux disease (GERD) is a disorder in which the normal function of the lower esophageal sphincter at the junction of the distal esophagus and stomach fails, allowing gastric fluid to reflux into the esophagus. Estimates suggest the prevalence of GERD in the United States ranges from 18% to 28%, with up to 40% of patients with GERD exhibiting an inadequate response to first-line treatment with pharmacotherapy.

Technology Description: Magnetic sphincter augmentation (MSA) with the LINX Reflux Management System includes an expandable, circumferential bracelet of magnetic beads that is implanted via laparoscope around the external distal esophagus at the gastroesophageal junction. The magnetic forces of the beads hold the junction closed, preventing gastroesophageal reflux but enabling normal function of the esophagus.

Controversy: Laparoscopic fundoplication for treatment of GERD is a complex surgical procedure with the possibility of complications such as GERD recurrence, chronic dysphagia, gas, bloating, inability to belch or vomit, irreversible anatomical alterations, and potential for scarring. MSA is a minimally invasive reversible procedure that maintains the physical anatomy and function of the esophagus. It is unknown whether MSA is equally effective as laparoscopic fundoplication yet associated with fewer side effects.

Key Questions:

  • Does MSA with the LINX Reflux Management System improve GERD-related symptoms?
  • How does MSA with the LINX Reflux Management System compare with standard treatments for GERD?
  • Is MSA with the LINX Reflux Management System safe?
  • Have definitive patient selection criteria been identified for MSA with the LINX Reflux Management System?

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