A Post-Approval Study of the LINX® Reflux Management System
Purpose: This is a prospective, multicenter, single-arm study, with patients as their own control to monitor the safety and efficacy of the LINX implant procedure and device in a post-approval environment to supplement existing safety and efficacy data.
The study population for this trial is patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.
Brian Louie, M.D.
Swedish Thoracic Surgery / First Hill