Torax Medical said today that data from a new study of its Linx reflux management system reported the treatment to be as effective as the standard-of-care Laproscopic Nissen Fundoplication treatment.
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 study analyzed data from 100 patients, 50 treated with LNF and 50 with Torax’s magentic sphincter augmentation treatment. At 1-year, patients had similar quality of life scores and proton-pump inhibitor use, the study reports.
No patients treated with MSA reported severe gas and bloating, compared to 10.6% of patients treated with LNF. MSA patients also had significanlty lower rates of inability to belch or vomit at 8.5% and 4.3% versus 25.5% and 21.3%, respectively.
“This is the 1st propensity matched study comparing Linx to LNF assessing quality of life, proton-pump inhibitor use, satisfaction and complications. This study validates the Linx results shown in other studies and substantiates that Linx is as effective as LNF in controlling reflux. It further supports the use of Linx as a 1st line therapy in patients who are failing drugs to control their reflux,” chief of upper GI and general surgery at USC’s Keck School of Medicine Dr. John Lipham said in a press release.
The study results were published in the Journal of the American College of Surgeons.
Last month, Torax won FDA approval for the next generation of its Linx reflux management system with MRI compatibility. 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.