The US Food and Drug Administration’s Gastroenterology and Urology Devices Advisory Panel has voted unanimously to endorse the approval of the LINX Reflux Management System (Torax Medical Inc), an implantable device for the treatment of pathologic gastroesophageal reflux disease (GERD) refractory to antireflux drug therapy. The 9-member panel voted a unanimous yes to all 3 questions, affirming the efficacy, safety, and favorable risk-benefit ratio for the novel treatment for GERD. The panel praised the sponsor and the FDA for the excellent quality of their presentations.
