Torax Medical said today that it won FDA approval for the next generation of its Linx reflux management system with MRI compatibility.
The Linx system is an implant composed of interlinked titanium beads with magnetic cores that augments the esophageal sphincter’s barrier function to prevent reflux in patients with gastro-esophageal reflux disease, the St. Paul, Minn.-based company said.
The new system is compatible with MRI systems because it contains a different grade of magnets that have a higher resistance to being demagnetized when subjected to external magnetic fields, the company said. The system will be safe for use with up to 1.5 tesla MRI machines.
“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,” CEO Todd Berg said in a press release.