FDA Approves MRI-Compatible Linx Device From Torax Medical

The U.S. Food and Drug Administration (FDA) has approved a next generation Linx Reflux Management System from Torax Medical Inc. that is magnetic resonance-conditional in magnetic resonance imaging (MRI) systems up to 1.5 Tesla (1.5T), which represents about 90 percent of MRI systems in use in the United States.

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 (i.e. MRI).

“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,” said Todd Berg, president/CEO of Torax Medical.

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, according to the company. 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 Reflux Management System is indicated for those patients diagnosed with gastro-esophageal reflux disease (GERD) as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.

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. Symptoms of GERD include heartburn and regurgitation, often associated with chronic sleep disruption, and may also include persistent cough, excessive throat clearing, hoarseness and a feeling of a “lump” in the throat. The alternative surgical option to Linx is Nissen fundoplication, wherein doctors reconstruct a new reflux barrier using a portion of the patient’s stomach, which is wrapped around the lower portion of the esophagus.

A study recently confirmed the long-term results of the Linx Reflux Management System in controlling reflux-related symptoms and eliminating dependence on acid suppression medications called proton pump inhibitors (PPIs). Findings from the clinical study demonstrated that the Linx procedure normalized the amount of acid in the esophagus, while safely and effectively relieving heartburn and regurgitation, and improving quality of life without the need for PPIs. The Linx device was approved by the FDA in early 2012 and currently is the only medical device approved by the FDA to be safe and effective for the treatment of gastro-esophageal reflux disease, company officials claim.

All patients included in the Linx study had pathologic levels of acid in their esophagus, had compromised quality of life from their reflux disease and were refractory to continuous PPI therapy (median duration of treatment with PPIs was five years). The study’s efficacy endpoints for success at five years, restored quality of life and reduced PPI dependence, both were met.

Study data showed that at five years:

• 85 percent of patients were free from daily dependence on PPIs;
• Bothersome heartburn was reduced to 11.9 percent from 89 percent at baseline; and
• Bothersome regurgitation was reduced to 1.2 percent from 57 percent at baseline

Because medications are less effective at managing regurgitation, the near elimination of regurgitation in this clinical study after Linx represents a significant benefit for patients with this symptom, bigwigs said. Importantly, no new safety risks emerged during the five-year follow-up period. If needed, the device can be removed and the rates for reoperation were less than the expected range for other anti-reflux procedures at five years. Overall, patients in this clinical study achieved significant clinical benefits from the Linx procedure; these benefits now are shown to be sustained at five years.