Clinical Study Shows Efficacy And Safety Of LINX Reflux Management System For Gastro-Oesophageal Reflux Disease

Main Category: GastroIntestinal / Gastroenterology
Article Date: 26 Feb 2013 - 1:00 PST


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

• The majority of treated patients were able to substantially reduce or resolve their reflux symptoms, while eliminating their use of reflux related medications.
• Severe regurgitation was eliminated in 100% of patients.
• Nearly all patients (93%) reported a significant decrease in the need for medication.
• More than 9 in 10 patients (94%) reported satisfaction with their overall condition after having the LINX System, compared to 13% before treatment while takingmedication.

The most frequent adverse event observed in the study was dysphagia (difficultyswallowing) and is most commonly mild to moderate and resolves with time. Other adverse events include bloating, pain, odynophagia, hiccups, nausea, and inability to belch or vomit. Within this, six incidences were defined as serious, and in six patients the device was removed.

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

• The LINX System, developed by Torax Medical, is a small, flexible band of interlinked titanium beads with magnetic cores that helps create a barrier to the reflux of acid and bile.
• The LINX System offers a new treatment option for GORD, reducing reflux and eliminating symptoms through a simple, reversible procedure.3
• People with GORD have a weak Lower Oesophageal Sphincter (LOS), a ring of muscle at the junction of the oesophagus and stomach that acts like a valve allowing food and drink to pass into the stomach.
• Normally the LOS closes after swallowing but in people with GORD the LOS allows acid and bile to 'reflux' from the stomach back into the oesophagus.
• With the LINX System, swallowing forces temporarily break the magnetic bond to allow food and drink to pass normally through the LOS. The magnets then close the LOS immediately after swallowing to restore the body's natural barrier to the reflux of acid and bile.
• The LINX System is placed around the oesophagus just above the stomach using a common surgical technique, called keyhole surgery, which is generally completed in less than an hour.
• The LINX System starts to work as soon as it is in place and patients should be able to resume a normal diet within a few hours of surgery and can usually return to normal activities in less than a week.3
• The LINX System has received the European CE Mark and has recently been approved by the US Food and Drug Administration.
• The LINX System is currently being used to treat patients with GORD in the United Kingdom, Italy and Germany.

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