The FDA advisory panel unanimously voted yes to all three questions posed by the FDA, affirming efficacy, safety and risk-benefit ratio for the LINX® Reflux Management System. The advisory panel meeting was the most recent milestone in the FDA regulatory review process for Torax Medical.
"Torax Medical is very pleased that the Gastroenterology and Urology Devices Advisory Panel recognized the clinical benefits of the LINX System. We look forward to working with the FDA to reach a final decision on approval to make the LINX treatment available to patients in the United States," commented Todd Berg, chief executive officer of Torax Medical.
The LINX Device
The LINX Reflux Management System incorporates 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 is intended to help the sphincter resist opening to gastric pressure, preventing reflux from the stomach into the esophagus. Higher pressures from swallowing can overcome the magnetic forces, allowing food and liquid to pass normally into the stomach.
About Torax Medical
Torax Medical Inc. is a privately held medical device company headquartered in St. Paul, Minnesota that develops and markets products designed to treat sphincter disorders. Torax Medicals technology platform, Magnetic Sphincter Augmentation (MSA), is currently marketed in Europe as the LINX® Reflux Management System for the treatment of Gastroesophageal Reflux Disease (GERD) and the FENIX™ Continence Restoration System for the treatment of Fecal Incontinence (FI). In the United States, the LINX System is not approved for commercial distribution and is currently limited by Federal law to investigational use. For more information, please visit www.toraxmedical.com.
Posted by Sean Fenske, Editor-in-Chief, MDT