Antireflux Transoral Incisionless Fundoplication Using EsophyX: 12-Month Results of a Prospective Multicenter Study

Background A novel transoral incisionless fundoplication (TIF) procedure using the EsophyX system with Serosa-Fuse fasteners was designed to reconstruct a full-thickness valve at the gastroesophageal junction through tailored delivery of multiple fasteners during a single-device insertion. The safety and efficacy of TIF for treating gas-troesophageal reflux disease (GERD) were evaluated in a prospective multicenter trial. Methods Patients (n = 86) with chronic GERD treated with proton pump inhibitors (PPIs) were enrolled. Exclu-sion criteria included an irreducible hiatal hernia [ 2 cm. Results The TIF procedure (n = 84) reduced all hiatal hernias (n = 49) and constructed valves measuring 4 cm (2–6 cm) and 230 (160–300). Serious adverse event