The US Food and Drug Administration's (FDA) Gastroenterology and Urology Devices Advisory Panel has affirmed efficacy, safety and risk-benefit ratio for Torax Medical's LINX reflux management system, a novel device for the treatment of Gastroesophageal Reflux Disease (GERD).
The company’s reflux management system comprises a small flexible band of interlinked titanium beads with magnetic cores, which is laparoscopically placed around the esophageal sphincter.
The magnetic attraction between the beads will help the sphincter resist opening to gastric pressure, preventing reflux from the stomach into the esophagus.
Torax Medical CEO Todd Berg said they look forward to working with the FDA to reach a final decision on approval to make the LINX treatment available to patients in US.
US-based Torax Medical is focused on developing and marketing products designed to treat sphincter disorders.