Torax Medical, Inc., points us at new data from a 415 patient, multi-institutional study, comparing its Linx® magnetic sphincter augmentation to laparoscopic Nissen fundoplication (LNF) for control of gastroesophageal reflux.
Background
Readers of our pages will know all about Torax Medical’s Linx system of interlinked titanium beads with magnetic cores, which augment the function of the esophageal sphincter and so play their part in the management of Gastroesophageal Reflux Disease (GERD). GERD results 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.
While drugs play their part in moderating gastric acid production, they do not repair the sphincter defect. If this is required, options are limited to so-called anti-reflux surgery, termed Nissen fundoplication in which new reflux barrier is constructed using a portion of the patient’s stomach, which is wrapped around the lower portion of the esophagus.
Contrastingly the LINX Reflux Management System is based on magnetic attraction between the beads, which 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.
The newly cited study was led by Brian Louie, MD, Director, Thoracic Research and Education and colleagues from the Swedish Medical Center in Seattle, Washington, together with collaborating centers.
The authors compared patients with GERD undergoing anti-reflux surgery with the Linx Reflux Management System to the standard of care, LNF at one year. The results demonstrated that LINX achieves similar improvements in symptomatic relief of reflux with fewer side effects. Additionally, patients who underwent the LINX procedure were more likely to report they would undergo the procedure again.
Investigator comments
“This study puts LINX as a first-line therapy for GERD as it preserves the patient’s gastric anatomy and minimizes side effects which are well established limitations of the current standard of care Nissen fundoplication” said Dr. Brian Louie. “LINX is a needed and effective surgical treatment option for patients with GERD that are not adequately controlled with medical therapy.”
The study results were published in Surgical Endoscopy (http://www.ncbi.nlm.nih.gov/pubmed/26541740).
Source: PR Newswire
published: December 2, 2015 in: Clinical Studies/Trials, General Surgery