Focus of the Report: The focus of this Health Technology Assessment (HTA) is to evaluate the effectiveness and safety of magnetic sphincter augmentation (MSA) with the LINX Reflux Management System (Torax Medical Inc., acquired by Ethicon Inc.) for the treatment of gastroesophageal reflux disease (GERD).

Technology Description: The LINX device is an expandable circumferential bracelet of magnetic beads that is implanted via laparoscope around the external distal esophagus at the gastroesophageal junction in an outpatient setting. The magnetic forces of the beads hold the junction closed, preventing gastroesophageal reflux but enabling normal function of the esophagus.

Controversy: Laparoscopic fundoplication (LF) carries the possibility of complications, such as GERD recurrence, need for repeat surgery, chronic dysphagia, gas, bloating, and inability to belch or vomit. Clinical outcomes appear to be dependent on expertise of the surgeon and volume of the center in which it is performed. MSA is a minimally invasive reversible procedure that maintains the physical anatomy and function of the esophagus. While MSA is less invasive than LF and may result in fewer complications, it is unknown whether MSA is equally effective.

Key Questions:

  • Is MSA with the LINX Reflux Management System effective for improving 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 for GERD?

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