OBJECTIVES: One- and 2-year evaluation of a feasibility trial 
(clinicaltrials.gov registration numbers NCT01057992, NCT01058070, and 01058564) 
to assess the safety and efficacy of a laparoscopically implanted sphincter 
augmentation device for the treatment of gastroesophageal reflux disease (GERD).
METHODS: A sphincter augmentation device (LINX Reflux Management System; Torax 
Medical, Shoreview, MN), designed to prevent reflux due to abnormal opening of 
the lower esophageal sphincter (LES), was laparoscopically implanted at the 
gastroesophageal junction in 44 patients. At baseline, all patients had abnormal 
esophageal acid exposure on 24-hour pH monitoring and improved, but persistent, 
typical GERD symptoms while on acid suppression therapy with proton pump 
inhibitors (PPIs). The device comprises a miniature string of interlinked 
titanium beads, with magnetic cores, placed around the gastroesophageal 
junction. The magnetic bond between adjacent beads augments sphincter 
competence. The beads temporarily separate to accommodate a swallowed bolus, 
allow belching or vomiting, and reapproximate to augment the LES in the closed 
position. Patients were evaluated after surgery by GERD Health-Related Quality 
of Life symptom score, PPI usage, endoscopy, esophageal manometry, and 24-hour 
esophageal pH monitoring.
RESULTS: The total mean GERD Health-Related Quality of Life symptom scores 
improved from a mean baseline value of 25.7 to 3.8 and 2.4 at 1- and 2-year 
follow-up, representing an 85% and 90% reduction, respectively (P < 0.0001). 
Complete cessation of PPI use was reported by 90% of patients at 1 year and by 
86% of patients at 2 years. Early dysphagia occurred in 43% of the patients and 
self-resolved by 90 days. One device was laparoscopically explanted for 
persistent dysphagia without disruption of the anatomy or function of the 
cardia. There were no device migrations, erosions, or induced mucosal injuries. 
At 1 and 2 years, 77% and 90% of patients had a normal esophageal acid exposure. 
The mean percentage time pH was less than 4 decreased from a baseline of 11.9% 
to 3.1% (P < 0.0001) at 1 year and to 2.4% (P < 0.0001) at 2 years. Patient 
satisfaction was 87% at 1 year and 86% at 2 years.
CONCLUSIONS: The new laparoscopically implanted sphincter augmentation device 
eliminates GERD symptoms without creating undue side effects and is effective at 
1 and 2 years of follow-up.