Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study

Ann Surg. 2019 Aug;270(2):302-308. doi: 10.1097/SLA.0000000000002789.


Objective: To report 1-year results from a 5-year mandated study.

Summary background data: In 2012, the United States Food and Drug Administration approved magnetic sphincter augmentation (MSA) with the LINX Reflux Management System (Torax Medical, Shoreview, MN), a novel device for the surgical treatment of gastroesophageal reflux disease (GERD). Continued assessment of safety and effectiveness has been monitored in a Post Approval Study.

Methods: Multicenter, prospective study of patients with pathologic acid reflux confirmed by esophageal pH testing undergoing MSA. Predefined clinical outcomes were assessed at the annual visit including a validated, disease-specific questionnaire, esophagogastricduodenoscopy and esophageal pH monitoring, and use of proton pump inhibitors.

Results: A total of 200 patients (102 males, 98 females) with a mean age of 48.5 years (range 19.7-71.6) were treated with MSA between March 2013 and August 2015. At 1 year, the mean total acid exposure time decreased from 10.0% at baseline to 3.6%, and 74.4% of patients had normal esophageal acid exposure time (% time pH<4 ≤5.3%). GERD Health-Related Quality of Life scores improved from a median score of 26.0 at baseline to 4.0 at 1 year, with 84% of patients meeting the predefined success criteria of at least a 50% reduction in total GERD Health-Related Quality of Life score compared with baseline. The device removal rate at 1 year was 2.5%. One erosion and no serious adverse events were reported.

Conclusions: Safety and effectiveness of magnetic sphincter augmentation has been demonstrated outside of an investigational setting to further confirm MSA as treatment for GERD.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Deglutition / physiology*
  • Esophageal Sphincter, Lower / physiopathology
  • Esophageal Sphincter, Lower / surgery*
  • Esophageal pH Monitoring
  • Female
  • Follow-Up Studies
  • Gastroesophageal Reflux / metabolism
  • Gastroesophageal Reflux / physiopathology
  • Gastroesophageal Reflux / surgery*
  • Humans
  • Magnets*
  • Male
  • Middle Aged
  • Prospective Studies
  • Prosthesis Design
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Young Adult