Enteryx® Procedure for the Treatment of GERD Symptoms

Abstract

Purpose: To evaluate the long term safety and effectiveness of Enteryx, an endoscopically implanted biocompatible copolymer for the treatment of gastroesophageal reflux disease (GERD) symptoms. Methods: Proton pump inhibitor (PPI)-dependent and PPI-responsive patients were part of a multicenter, FDA-mandated Post Approval Study designed to follow 300 patients for 36 months post Enteryx procedure. To date, 60 patients completed 36 months of follow-up. Exclusion criteria included esophageal varices, Barrett's esophagus, and poor candidacy for endoscopy. Primary study endpoint was reduction of PPI dose by at least 50% at 12, 24, and 36 months. Secondary objective was GERD health-related quality of life (GERD-HRQL) score assessment. Follow-up occurred at months 1, 6, 12, 24, and 36. Safety was assessed as the incidence of adverse events. Results: At 36 months post Enteryx procedure, 65.0% of patients reduced PPI use by at least 50%; 48.3% eliminated daily PPI use compared to baseline. Median GERD-HRQL heartburn score improvement at month 36 was 76.4% compared to baseline off PPI therapy prior to treatment (p < 0.0001); median GERD-HRQL regurgitation score improvement at month 36 was 80.0% (p < 0.0001). Adverse events (AEs) related to Enteryx generally occurred and resolved during the immediate post-implantation period. One mild case of dysphagia occurred around 24 months and resolved without treatment. Exact logistic regression of baseline measures (e.g., demographics, symptom severity, PPI use) showed no predictors of a treatment response at 36 months. Conclusions: At 36 months post-Enteryx® procedure, nearly two-thirds of patients had substantial reduction of PPI use, with almost one-half of patients eliminating daily PPI use. The improvement in GERD-HRQL heartburn and regurgitation scores relative to baseline persisted throughout 36 months. No significant predictive value of preimplantation variables was noted.