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Linx Reflux Management System

First submitted by:
Heidi Ryan
Category
Emerging Technologies
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How Linx works

Linx is a small, flexible band of rare-earth magnet beads covered in titanium alloy and linked by wires which is placed around the lower esophageal sphincter (LES) for treatment of gastroesophageal reflux (GERD). The magnetic force of the band is greater than the increased gastric pressure associated with GERD, therefore augmenting the resistance of the esophageal sphincter to abnormal opening associated with reflux. The beads separate and band expands when swallowing a food bolus, belching, or vomiting because the magnetic force if the beads is overcome by these processes.

Indications

Candidates for the LINX reflux management systems are patients ages 21-75 with typical symptoms of GERD for six months taking daily proton pump inhibitors (PPI) who continue to have symptoms. Diagnosis of GERD is defined by abnormal pH testing.

Contraindications

Precaution should be used in the following patients as safety and effectiveness haven’t been evaluated:

  • hiatal hernia (<3cm),
  • erosive esophagitis grades B, C, or D,
  • BMI > 35
  • Electrical implants or metallic abdominal implants
  • Major motility disorders
  • Scleroderma
  • Esophageal or gastric cancer
  • Distal amplitude < 35 mmHg or < 70% peristaltic sequences
  • Esophageal stricture or gross anatomic abnormality
  • Lactating, pregnant or plan to become pregnant

Currently the LINX system has not been approved for use in MRI. Patients with allergies to titanium, stainless steel, nickel, or ferrous material should not be considered.

Procedure

The band is placed via a laparoscopic approach during an outpatient surgical procedure. Patients are instructed to resume a normal diet post operatively, which allows for expansion of the bracelet as a capsule forms. This prevents stricture.

Effectiveness

In a prospective study of 100 patients three years after sphincter augmentation, 64% of patients achieved either normalization of or at least 50% reduction in esophageal acid exposure.(1) A reduction in the average daily dose of proton pump inhibitors of at least 50% was achieved in 93% of patients.

Endoscopic evidence of esophagitis was reduced from 40% before surgery to 12% at one year and 11% at two years.

Side effects/complications

The most commonly reported side effect of the sphincter augmentation is dysphagia (68%) and is usually mild. Ongoing dysphagia occurred at 11% after one year, 5% after two, and 4% at three years. Other side effects commonly reported after the Nissen fundoplication including an inability to vomit, abdominal bloating, and flatulence are rare with the Linx.

The procedure is reversible. The explantation rate is currently 3%. Most explanations are required due to intractable dysphagia. No erosions or migrations have been reported.

References

1. RA Ganz, et al. Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med 2013; 368:719-27.

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