Medical Devices: Evidence and Research (Aug 2018)

Spotlight on the Linx™ Reflux Management System for the treatment of gastroesophageal reflux disease: evidence and research

  • Zadeh J,
  • Andreoni A,
  • Treitl D,
  • Ben-David K

Journal volume & issue
Vol. Volume 11
pp. 291 – 300

Abstract

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Jonathan Zadeh, Anthony Andreoni, Daniela Treitl, Kfir Ben-David Department of Surgery, Mount Sinai Medical Center, Miami Beach, FL, USA Background: The initial approach to gastroesophageal reflux disease (GERD) management typically involves lifestyle modification and medical therapy utilizing acid reducing agents such as histamine blockers and proton pump inhibitors. In severe cases refractory to such treatments, surgical therapy may be indicated. The gold standard for surgical treatment of GERD is the laparoscopic Nissen fundoplication. In recent years, a new technique known as magnetic sphincter augmentation (MSA) has been developed using the Linx™ Reflux Management System. This is an implantable ring of magnetic beads that is placed around the esophagus at the gastroesophageal junction to restore lower esophageal integrity. The aim of this review is to discuss the current literature regarding indications, surgical technique, efficacy, and complications of MSA using the Linx device. Methods: A standardized literature search was performed yielding 367 abstracts. After elimination due to duplicates between databases and irrelevance, 96 articles remained. The information found to be significant and non-redundant was included in this review. Conclusion: After several years of clinical application, the Linx device has been shown to not only be effective for the management of GERD but also be as effective as fundoplication. With respect to safety, the most common complication of MSA is dysphagia. This often resolved without intervention, but esophageal dilation or device explanation are occasionally necessary. Not fully appreciated in earlier reviews, erosion of the device into the esophagus appears to be the most significant complication of the device after extended follow-up. While very rare, the potentially severe consequences of this phenomenon suggest that the device should be used with some restraint and that patients should be made aware of this potential morbidity. Fortunately, in the few cases of device erosion described in the literature reviewed, the Linx device was easily and safely removed. Keywords: Linx, magnetic sphincter augmentation, GERD, Nissen fundoplication

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