LINX® Reflux Management System
The LINX® Reflux Management System, also known as LINX® System, offers a new treatment option for Gastro-oesophageal Reflux Disease (GORD), reducing reflux and eliminating symptoms through a simple, reversible procedure.
What is the LINX®Reflux Management System?
- The LINX® Reflux Management System, also known as LINX® System, offers a new treatment option for Gastro-oesophageal Reflux Disease (GORD), reducing reflux and eliminating symptoms through a simple, reversible procedure.
- 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.
What are the symptoms of GORD?
- Common symptoms of GORD include heartburn, regurgitation and chest pain – these can be severe and persist over time.
- If GORD is left untreated serious complications can occur, such as Barrett’s oesophagus and oesophageal cancer.
How does the LINX® system work?
- The LINX® System is a small, flexible band of interlinked titanium beads with magnetic cores that helps create a barrier to the reflux of acid and bile.
- 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.
- Unlike other surgical treatments, the LINX® System allows belching and vomiting.
Why is LINX® System needed?
- Most people with GORD will be put on medication to relieve symptoms, however this does not prevent reflux
- Many people still experience the symptoms of GORD despite taking regular medication such as PPIs (proton pump inhibitors).
- In almost 40% of cases, GORD symptoms persist despite treatment with PPIs, even at a high dose.
- Until now, if GORD symptoms were not relieved by medication, the only other option was a complex surgical procedure called fundoplication. This operation involves wrapping part of the stomach around the oesophagus and therefore altering the anatomy of the stomach.
- Side effects associated with fundoplication include losing the ability to belch and vomit and chronic dysphagia (persistent difficulty when swallowing).
How effective is the LINX® System?
- The LINX® System reduces or eliminates the symptoms of GORD without creating undue side effects.
- A clinical study of the LINX® System showed excellent relief of GORD symptoms and significantly reduced levels of acid exposure in the oesophagus two years post implant.
- This study also shows that two years post implant:
- 86% of people have completely stopped taking medication for GORD
- 86% of patients are satisfied with their condition.
- 90% of patients have a normal level of acid exposure in the oesophagus.
What are the side effects of the LINX®System?
- Side effects following the LINX® System procedure are minimal1c and generally resolve over time.
- Mild dysphagia (discomfort when swallowing) occurs in less than half of patients after the LINX® System procedure and is generally resolved within 90 days without treatment.
- The LINX® System procedure does not involve any changes to the anatomy of the stomach and is fully and easily reversible.
- The first LINX® Reflux Management System procedure took place in 2007 and since then, there have been no reports of injury or damage to the oesophagus or surrounding tissue and there have been no reports of the device migrating from the site of implantation.
- Torax® Medical Inc. is committed to the safe and effective long-term use of the LINX® Reflux Management System. The LINX® System has undergone rigorous testing to ensure its safety and efficacy and every patient is entered into a registry to track their recovery and progress in the years following implantation.
What approval processes has the LINX®System had to go through?
- The LINX® System has undergone rigorous testing and is CE marked in Europe. When a product has been marked with ‘CE’ it means that the manufacturers have declared that the product has met all the requirements for it to be used in Europe.
- The LINX® System has now been approved by both NICE and the US Food and Drug Administration (FDA). See the following: https://www.nice.org.uk/guidance/ipg431 + http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm300790.htm
To find out more about the LINX® System, please visit: www.toraxmedical.com/linx
Watch the procedure: http://www.youtube.com/watch?v=GCJZaMXvY-Y&feature=youtu.be
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