LINX Receives FDA Panel Recommendation

The future looks bright for reflux sufferers. In January 2012, Torax Medical’s LINX Reflux Management System received a unanimous recommendation from the FDA’s Gastroenterology and Urology Devices Advisory Panel.

“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.

Using magnetized titanium interlinked beads, the LINX is placed around the Lower Esophageal Sphincter (LES) to provide assistance to prevent reflux from the stomach from flowing back into the esophagus.   The LINX’s design allows the force of swallowing to break the magnetic bond between the beads, causing them to expand and direct the passage of solids and liquids into the stomach.  Then, the magnetized beads are designed to pull back together, forcing the LES to close and prevent any reflux from passing back up the esophagus.

The LINX is put in place via a minimally invasive laparoscopic surgical procedure using a sizing tool to ensure a correct fit and suture tails to ensure position and correct closure.

The LINX has been sold in the United Kingdom, Germany, and Italy for the past two years.  An impending FDA approval holds much promise for the 19 millions of Americans who suffer from reflux disease. Currently, non-surgical treatments are limited to elevating the head while sleeping, losing weight, making dietary changes, and taking medications such as antacids, H2 blockers, or proton-pump inhibitors.  If these methods don’t work, the only other alternative for U.S. patients is a surgical procedure that uses a flap cut from the stomach to wrap around the esophagus.