Magnetic Augmentation of the Lower Esophageal Sphincter: Results of a Feasibility Clinical Trial

Abstract

Laparoscopic implant of the MSA device is safe and well tolerated. It requires minimal surgical dissection and a short learning curve compared to the conventional Nissen fundoplication.

LINX® Reflux Management System in chronic gastroesophageal reflux: a novel effective technology for restoring the natural barrier to reflux

“…Patients are discharged on the same day or on the first postoperative day and are told to return to a normal diet as tolerated and discontinue use of acid suppression medication. [Bonavina et al 2008[Bonavina et al , 2010Lipham et al 2012]. The second study (pivotal trial) [ClinicalTrials.gov identifier: NCT00776997] evaluated 100 patients implanted with the device in 13 centers between January and September 2009 [Ganz et al 2013].…”

Esophageal Sphincter Device for Gastroesophageal Reflux Disease

“…This rate of persistent dysphagia is similar to that observed in the pilot study and in registries in the United States and Europe. 10,11 Removal of the device was required in six patients within 21 days to 2.9 years after placement. The possibility of easy removal of the device after a longer interval is unknown.…”

“…The device involves the use of magnetic attraction through adjacent magnetic beads, which augments the resistance of the esophageal sphincter to abnormal opening associated with reflux. [9][10][11] Each bead contains a sealed core of magnetic neodymium iron boride that produces a precise and permanent force of attraction. The beads are connected to adjacent beads by small wires that allow the device to expand.…”

“…7,8 Augmentation of the esophageal sphincter with a magnetic device may provide an alternative treatment for patients who have incomplete symptom relief with proton-pump inhibitors or who are reluctant to undergo surgical fundoplication. [9][10][11] The aim of magnetic sphincter augmentation is to improve the barrier function of the sphincter without altering the hiatal and gastric anatomy or interfering with swallowing, belching, or vomiting. The feasibility of this concept was shown in a pilot study.…”

Magnetic Augmentation of the Lower Esophageal Sphincter: Changing the Treatment Paradigm in Patients with Gastroesophageal Reflux Disease

“…The fi rst study evaluated 44 patients implanted at 4 centers with the Linx device between February 2007 and October 2008 [ 19 ] . Data from this study were submitted for CE certi fi cation and showed the device to have a positive risk-to-bene fi t ratio.…”