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In 2012, the U.S. Food and Drug Administration approved the use of a magnetic device that augments the lower esophageal sphincter function as an intervention option for patients with symptomatic gastroesophageal reflux disease (GERD). The current study provides final 5-year data on safety and efficacy of the device, updating a prior report of 3-year follow-up data (NEJM JW Gastroenterol May 2013).
The industry-funded, multicenter study initially comprised 100 patients with partial response to daily proton-pump inhibitors (PPIs) and evidence of pathologic reflux on 24-hour pH monitoring who underwent implantation of the magnetic device. Five-year follow-up data, available for 85 patients, showed that postapproval efficacy endpoints of ≥50% im…