Clinical Study Shows Efficacy And Safety Of LINX Reflux Management System For Gastro-Oesophageal Reflux DiseaseMain Category: GastroIntestinal / Gastroenterology
Article Date: 26 Feb 2013
The results of a study providing clinical evidence of safety and effectiveness for Torax Medical's LINX® Reflux Management System, an innovative approach to treating gastro-oesophageal reflux disease (GORD), are published in the current edition of the New England Journal of Medicine (NEJM).1
The LINX System was studied in a prospective and controlled trial involving 14 European and US Medical centres.1 The patients were evaluated before and after treatment to determine the effect of the LINX System on their GORD using pre-defined success criteria that included reduction of oesophageal acid, improvement in quality of life, and elimination of reflux medications.1
The primary endpoint, normalisation of oesophageal acid exposure or a 50% or greater reduction in exposure at 1 year, was achieved in 64% of patients. The 3-year results of the 5-year study demonstrated that following the LINX procedure:1
Mr Saj Wajed, Consultant Upper Gastro-Intestinal (GI) Surgeon, who is a specialist in upper GI laparoscopic (keyhole) surgery, said: "These results are extremely encouraging and support my direct observations with the LINX System in clinical practice. The LINX System fills the treatment gap for patients whose symptoms are either poorly controlled by acid suppression medications, or for those are dependent on these drugs but who do not wish to undergo complex surgery, which involves wrapping the upper stomach around the oesophagus, and currently the only other effective treatment option for GORD."
GORD is a common condition where stomach acid leaks from the stomach into the oesophagus.1 It is estimated that 1 in 5 people in the UK will have at least one episode of GORD a week, suffering symptoms including regurgitation, chest pain, nausea, coughing and difficulty swallowing.2 These symptoms can be severe and persist over time. If GORD is left untreated, serious complications can occur, such as oesophagitis, swallowing difficulties, Barrett's oesophagus (a pre-cancerous condition) and oesophageal cancer.2
The LINX System is a small, flexible band of titanium beads with magnetic cores that is placed around the oesophagus, just above the stomach. It is designed to restore the body's natural barrier to reflux and eliminate the symptoms associated with GORD. Until now, if GORD symptoms were not relieved by medication, the only otheroption available was a non-reversible procedure known as fundoplication which involves altering the anatomy of the stomach by wrapping part of it around the oesophagus.
The LINX System has been available privately in the UK since April 2011, as well in three NHS hospitals since 2012. Approximately 50 patients from across the UK have benefited from the procedure to date. About the LINX System
Original article posted on Medical News Today.
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