An Evaluation of the Medtronic Gatekeeper System in the Treatment of SUBJECTS With Gastroesophageal Reflux Disease (GERD)

Diagnosis and main criteria for inclusion: * Subjects diagnosed with GERD with symptomatic improvement on PPIs. * Subjects who have demonstrated a baseline 24 Hour pH ≥ 4% time with pH ≤ 4.0. * Subjects with a baseline GERD-HRQL heartburn score of ≤11 on PPI and ≥ 20 off PPI. Diagnosis and main criteria for exclusion: * Extensive Barrett's Esophagus (\> 2 cm). * Esophagitis (LA Classification Grades C or D). * Previous history of gastroesophageal surgery, anti-reflux procedures, or gastroesophageal or gastric cancer. * Large hiatal hernia (\> 3 cm). * Current complaints of clinical dysphagia evidenced by greater than one occurrence per month. * Esophageal strictures * Esophageal or gastric varices