Torax Medical device approved by FDA

The Food and Drug Administration (FDA) has approved a next generation LINX Reflux Management System.

Gastro-esophageal Reflux Disease (GERD) is a chronic often progressive disease resulting from a weak lower esophageal sphincter, that allows harmful gastric fluid to reflux into the esophagus, resulting in both pain and injury to the esophageal lining. GERD is associated with a pre-cancerous condition known as Barrett’s esophagus which increases the risk of esophageal cancer.

LINX is a small implant comprised of interlinked titanium beads with magnetic cores. The magnetic attraction between the beads augments the existing esophageal sphincter’s barrier function to prevent reflux. The device is implanted using a standard minimally invasive laparoscopic procedure and is an alternative to the more anatomically disruptive fundoplication commonly used in surgical anti-reflux procedures.

The LINX system is MR conditional in magnetic resonance imaging (MRI) systems up to 1.5 Tesla (1.5T), which represents about 90% of MRI systems in use in the U.S. The LINX 1.5T design contains a different grade of magnets that have a higher resistance to being demagnetized when subjected to external magnetic fields.

Todd Berg, president and CEO of Torax Medical, said: “We are pleased to make this next generation LINX device available to patients seeking relief from their reflux symptoms while broadening their access to diagnostic imaging options after treatment.”

Patients considering the LINX procedure should consult their healthcare provider regarding any questions related to MR imaging. Patients who have already received a LINX implant should consult their provider prior to undergoing any MRI tests.