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Reflux is a disease, not a bad meal choice.
Reflux is a disease, not a bad meal choice.
Reflux (also called Gastro-oesophageal reflux disease, or GORD) is a chronic digestive disease in which acid and bile flow back from the stomach into the oesophagus, creating pain and often causing damage to the lining of the oesophagus.
What causes reflux disease?
Reflux disease is caused by inappropriate relaxation or weakness in a muscle called the lower oesophageal sphincter (LOS). Normally the LOS acts like a one-way valve allowing food and liquid to pass through to the stomach, but preventing stomach contents from flowing back into the oesophagus.
The most common symptom of reflux disease is heartburn. However, reflux disease can produce a wide variety of symptoms including: hoarseness, sore throat, cough, chest pain, shortness of breath, difficulty swallowing, asthma, heartburn, and regurgitation.
Patients living with reflux disease often experience:
Poor quality of sleep
Reduced work productivity
Dietary compromises to avoid symptoms
Concerns about the long-term effects of reflux disease
Life-long dependence on reflux medications
In addition to producing a wide range of symptoms, reflux disease can lead to potentially serious complications including:
- Oesophagitis (Inflammation that can damage the tissue of the oesophagus)
- Stricture (Narrowing of the oesophagus)
- Barrett’s oesophagus (Pre-cancerous changes to the tissue lining the oesophagus)
- Oesophageal cancer (uncommon)1†
There are several tests that your physician may use to diagnose reflux disease. Here are some examples:
- A medication trial may be used to confirm diagnosis in patients with typical symptoms.
- Oesophagogastroduodenoscopy (OGD), also known as upper Endoscopy, is a test that examines the oesophagus and LOS for evidence of reflux disease.
- pH monitoring using a probe in the Oesophagus near the stomach measures the level of oesophageal acid exposure.
Diet modifications to reduce or eliminate spicy/ acidic food, caffeine, chocolate, alcohol and tobacco. Lifestyle modification such as elevation of head of bed, no meals 2-3 hours before bed, and weight loss (in overweight patients).
The benefits of medication include reduced stomach acid production, reduced inflammation of the oesophageal lining, and relief from heartburn symptoms. However, medication does not address the mechanical cause of reflux disease (weakness of the lower oesophageal sphincter).2 Studies have shown that up to 40% of patients continue to have symptoms while on medication.3‡
Traditional Anti-Reflux Surgery: Fundoplication
Fundoplication surgery involves wrapping the upper part of the stomach around the outside of the oesophagus at the lower oesophageal sphincter to help prevent reflux. It has been shown to reduce symptoms of GORD and may also end dependence on medication.4
LINX Reflux Management System
LINX is a small, flexible ring of magnets placed around the oesophagus during a minimally invasive procedure. Unlike other surgical treatments for GORD§, LINX does not require changes to the stomach anatomy.5,6¶
* LINX is not intended to cure, treat, prevent, mitigate or diagnose these symptoms or complications
† The annual cancer risk for non-dysplastic Barrett’s oesophagus in persons with symptoms of gastro-oesophageal reflux disease varies between countries and ranges from 0.12% to 0.5% and 0.33% to 0.7% in population-based studies and in meta-analyses, respectively.
‡ Data relates to GORD symptoms in patients with large hiatal hernias.
§ As of January 28, 2020
¶ The surgical technique does not require active alteration of the stomach anatomy
1. Lenglinger J, Riegler M, Cosentini E, et al. Review on the Annual Cancer Risk of Barrett’s Esophagus in Persons with Symptoms of Gastroesophageal Reflux Disease. Anticancer Res. 2012;32:5465-73
2. Bell R, Lipham J, Louie B, et al. Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial. Gastrointest Endosc. 2019;89:14-22.e1.
3. Rona K, Reynolds J, Schwameis K, et al. Efficacy of magnetic sphincter augmentation in patients with large hiatal hernias. Surg Endosc. 2017;31:2096-2102.
4. Reynolds J, Zehetner J, Wu P, Shah S, Bildzukewicz N, Lipham J. Laparoscopic Magnetic Sphincter Augmentation vs Laparoscopic Nissen Fundoplication: A Matched-Pair Analysis of 100 Patients. J Am Coll Surg. 2015;221:123-128.
5. Bonavina L, Saino GI, Bona D et al. Magnetic augmentation of the lower esophageal sphincter: results of a feasibility clinical trial. J Gastrointest Surg. 2008;12:2133-40.
6. Asti E, Bonitta G, Lovece A, Lazzari V, Bonavina L. Longitudinal comparison of quality of life in patients undergoing laparoscopic Toupet fundoplication versus magnetic sphincter augmentation: Observational cohort study with propensity score analysis. Medicine (Baltimore). 2016;95:e4366.
LINX Reflux Management System Important Safety Information
The LINX Reflux Management System is indicated for patients diagnosed with pathologic Gastro-oesophageal Reflux Disease (GORD) as defined by abnormal pH testing, and who continue to have chronic GORD symptoms despite maximum medical therapy.
The LINX Reflux Management System is labelled for use by physicians only.
Contraindications: Do not implant the LINX Reflux Management System in patients with suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
Warnings: The LINX device is considered MR Conditional in a magnetic resonance imaging (MRI) system up to either 0.7 Tesla (0.7T) or 1.5 Tesla (1.5T), depending on the LINX model implanted. Scanning under different conditions may result in serious injury to you and/or interfere with the magnetic strength and the function of the device. In the event alternative diagnostic procedures cannot be used and MRI is required, the LINX device can be safely removed utilizing a laparoscopic technique that does not compromise the option for traditional anti-reflux procedures.
Failure to secure the LINX device properly may result in its subsequent displacement and necessitate a second operation.
General Precautions: The LINX device is a long-term implant. Explant (removal) and replacement surgery may be indicated at any time. Management of adverse reactions may include removal and/or replacement.
The LINX device has not been evaluated in patients with a hiatal hernia larger than 3 cm. Use of LINX device in patients with a hiatal hernia larger than 3 cm should be considered on the basis of each patient’s medical history and severity of symptoms.
The safety and effectiveness of the LINX device has not been evaluated in patients with Barrett's oesophagus or Grade C or D (LA classification) or Grade IV (Savary-Miller) oesophagitis.
The safety and effectiveness of the LINX device has not been evaluated in patients with electrical implants such as pacemakers and defibrillators, or other metallic, abdominal implants.
The safety and effectiveness of the LINX device has not been evaluated in patients with major motility disorders.
The safety and effectiveness of the LINX Reflux Management System has not been established for the following conditions:
- Suspected or confirmed oesophageal or gastric cancer
- Prior oesophageal or gastric surgery or endoscopic intervention
- Distal oesophageal motility less than 35 mmHg peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences or a known motility disorder such as achalasia, nutcracker oesophagus, and diffuse oesophageal spasm or hypertensive LOS
- Symptoms of dysphagia more than once per week within the last 3 months
- Oesophageal stricture or gross oesophageal anatomic abnormalities (Schatzki’s ring, obstructive lesions, etc.)
- Oesophageal or gastric varices
- Lactating, pregnant or plan to become pregnant
- Morbid obesity (BMI >35)
Potential Complications: Potential complications associated with the LINX Reflux Management System include achalasia (lower part of oesophagus does not relax), bleeding, death, device erosion (device passing through the oesophageal wall), device explant/re-operation, device failure, device migration (device does not appear to be at implant site), diarrhea, dysphagia (difficulty swallowing), inability to belch or vomit, infection, impaired gastric motility, injury to the oesophagus, spleen, or stomach, nausea, odynophagia (painful swallowing), organ damage caused by device migration, pain, peritonitis (inflammation of the peritoneum), pneumothorax (collapsed lung), regurgitation, saliva/mucus build-up, stomach bloating, vomiting, and worsening of preoperative symptoms (including but not limited to dysphagia or heartburn).
Please refer always to the Instructions for Use / Package Insert that come with the device for the most current and complete instructions.
Torax Medical, Inc.
4188 Lexington Avenue North
Shoreview, Minnesota 55126, USA