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LINX Reflux Management System
The LINX Reflux Management System is a flexible ring of small magnets placed around the esophagus just above the stomach during a minimally invasive procedure to help prevent reflux. LINX is intended for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximum medical therapy.
How LINX Works
Reflux occurs when a muscle called the lower esophageal sphincter (LES) is weak or relaxing inappropriately. This allows acid and bile to flow from the stomach into the esophagus. The magnets in LINX help to keep the LES closed so that acid and bile do not flow from the stomach to the esophagus. When you eat or drink, the forces from swallowing cause the magnets to separate, the LINX device to expand, and the LES to open for food or liquid to pass into the stomach.
Control reflux, long term1*
Reduced medication.
85% of patients were free from dependence on daily reflux medication after treatment with LINX.1†
Durable resolution of bothersome heartburn.
88% of patients reported being free of heartburn five years after treatment with LINX.1‡
Durable resolution of moderate to severe regurgitation.
LINX eliminated moderate to severe regurgitation in 98% of patients.1§
Significant decrease in gassiness and bloating.
Patients reported significant improvement in gassiness and bloating after treatment with LINX.1¶
Improved quality of life.
Patients reported significant improvement in quality of life after surgical treatment with LINX.1β
An alternative treatment to consider
Learn about the LINX procedure.
The LINX procedure is generally completed in less than one hour.2-4€ Most patients have same-day surgery or go home within 24 hours.4\\ Patients treated with LINX can resume a regular diet.5,6¥
Life with LINX
An inside look.
Designed to last long term. LINX is constructed from materials commonly used in other medical implants7,8$ and is MRI conditional.7Ω You should discuss the MRI scanning options with your doctor prior to deciding on treatment with the LINX system.
RestoreII, don't reconstruct.
Unlike other surgical treatments for GERD**, LINX does not require changes to the stomach anatomy. 3,9†† If necessary, LINX can be removed using a minimally invasive procedure. LINX preserves future treatment options for patients.1
Retained ability to belch and vomit.1,10‡‡
LINX preserves physiological function to belch and vomit.1,10§§ The titanium beads open and close to let food down, and if it needs to come up, it can.
Additional Treatment Options for GERD
Lifestyle Modification
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).
Medication
The benefits of medication include reduced stomach acid production, reduced inflammation of the esophageal lining, and relief from heartburn symptoms. However, medication does not address the mechanical cause of reflux disease. Studies have shown that up to 40% of patients continue to have symptoms while on medication.11¶¶
Traditional Anti-Reflux Surgery: Fundoplication
Fundoplication surgery involves wrapping the upper part of the stomach around the outside of the esophagus at the lower esophageal sphincter to help prevent reflux. It has been shown to reduce symptoms of heartburn, reflux, and bloating, and may also end dependence on medication.10
References
* Based on observation of 100 patients implanted with LINX. Bothersome heartburn decreased to 11.9% at 5 years from 89%(p<0.001), bothersome regurgitation decreased to 1.2% at 5 years from 57% (p<0.001), PPI dependence decreased to 15.3% at 5 years from 100% (p<0.001).
† Based on a study observing 100 patients who were implanted with LINX, daily use of PPIs decreased to 15.3% at 5 years. 84.7% were either completely off PPIs or reported use as needed at 5 years after surgery. (p<0.001)
‡ Based on a 5 year prospective, multi-center, single-arm study observing 100 patients who were implanted with LINX, bothersome heartburn was 89% at baseline and decreased to 11.9% at 5 years. (p<0.001)
§ Based on a 5 year prospective, multi-center, single-arm study observing 100 patients who were implanted with LINX, moderate to severe regurgitation was 57% at baseline and decreased to 1.2% at 5 years. (p<0.001)
¶ Based on a 5 year prospective, multi-center, single-arm study observing 100 patients who were implanted with LINX, symptoms of bloating/gas decreased from 52% at baseline to 8.3% at 5 years. (p<0.001)
β Based on a 5 year prospective, multi-center, single-arm study observing 100 patients who were implanted with LINX, there was a significant improvement in the median GERD-HRQL score at 5 years, as compared with baseline, both with and without PPI use, 4 vs 11 and 27 respectively (p<0.001).
€ Based on a prospective observational study of 67 patients that underwent placement of the LINX device between April 2012 and December 2013, a 6-year single-center prospective case series of 100 patients that underwent MSA, and an IDE trial involving 100 patients implanted with LINX. Median operative times were 60 minutes, 47 minutes, and 36 minutes, respectively.
\\ Based on a pivotal IDE trial of 100 subjects at 14 clinical sites. All patients were discharged within 1 day after surgery.
¥ As dictated by your healthcare professional
$ The LINX Reflux Management System device consists of titanium beads with magnetic cores that are connected with independent titanium wires. Titanium is a material used in multiple orthopaedic, cardiac and dental applications.
Ω This device can be scanned safely under the following conditions: 1) 1.5-Tesla static magnetic field, 2) maximum spatial gradient field of 17.15 T/m, 3) maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4.0 W/kg in First Level Controlled Operating Mode, and 4) the patient may feel pressure around the lower esophagus; should the patient experience pain, immediately discontinue the scan and remove the patient from the MR environment. Refer to IFU for warnings/MRI safety information.
II The LINX device is placed in the area of the Lower Esophageal Sphincter (LES) designed to augment a weak LES.
** As of January 28, 2020
†† The surgical technique does not require active alteration of the stomach anatomy
‡‡ Based on a prospective study of 100 adults who underwent MSA in which all patients reported the ability to belch and vomit (if necessary), and a retrospective matched-pair analysis of 1-year outcomes of 100 patients undergoing MSA and LNF from June 2010 to June 2013. After MSA 8.5% of patients were unable to belch compared to 25.5% of patients after LNF (p=0.028), and 4.3% of MSA patients were unable to vomit compared to 21.3% of LNF patients (p=0.004).
§§Based on a retrospective analysis of 1-year outcomes of patients undergoing MSA and LNF from June 2010 to June 2013. Matched-pair analysis of 100 patients. More LNF patients were unable to belch (8.5% of MSA and 25.5% of LNF; p= 0.028) or vomit (4.3% of MSA and 21.3% of LNF; p=0.004).
¶¶ Data relates to GERD symptoms in patients with large hiatal hernias.
1. Ganz R, Edmundowicz S, Taiganides P, et al. Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. Clin Gastroenterol Hepatol. 2016;14:671-677.
2. Reynolds J, Zehetner J, Bildzukewicz N, et al. Magnetic Sphincter Augmentation with the LINX Device for Gastroesophageal Reflux Disease after U.S. Food and Drug Administration Approval. The American Surgeon. 2014;80:1034-1038.
3. Bonavina L, Saino G, Bona D, et al. One Hundred Consecutive Patients treated with Magnetic Sphincter Augmentation for Gastroesophageal Reflux Disease: 6 Years of Clinical Experience from a Single Center. J Am Coll Surg. 2013;217:577-585.
4. Ganz R, Peters J, Horgan S, et al. Esophageal Sphincter Device for Gastroesophageal Reflux Disease. N Engl J Med. 2013;368:719-727.
5. Ayazi S, Zheng P, Zaidi A, et al. Magnetic sphincter augmentation and postoperative dysphagia: Characterization, clinical risk factors, and management. J Gastrointest Surg. 2020;24:39‐49.
6. Bonavina L, DeMeester T, Ganz R. LINX Reflux Management System: magnetic sphincter augmentation in the treatment of gastroesophageal reflux disease. Expert Rev Gastroenterol Hepatol. 2012;6:667-674
7. As per Instructions for Use
8. International Titanium Association. Medical Technology. Available from https://titanium.org/page/MedicalTechnology [Accessed 03 Nov 2020]
9. 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(30):e4366.
10. Reynolds J, Zehetner J, Wu P, et al. Laparoscopic Magnetic Sphincter Augmentation vs Laparoscopic Nissen Fundoplication: A Matched-Pair Analysis of 100 Patients. J American College of Surgeons. 2015;221:123-128.
11. Rona K, Reynolds J, Schwameis K, et al. Efficacy of magnetic sphincter augmentation in patients with large hiatal hernias. Surgical Endoscopy. 2017. 31:2096-2102.
LINX Reflux Management System Important Safety Information
The LINX Reflux Management System is indicated for patients diagnosed with pathologic Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximum medical therapy.
The LINX Reflux Management System is labeled 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 esophagus or Grade C or D (LA classification) or Grade IV (Savary-Miller) esophagitis.
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:
- Scleroderma
- Suspected or confirmed esophageal or gastric cancer
- Prior esophageal or gastric surgery or endoscopic intervention
- Distal esophageal motility less than 35 mmHg peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences or a known motility disorder such as achalasia, nutcracker esophagus, and diffuse esophageal spasm or hypertensive LES
- Symptoms of dysphagia more than once per week within the last 3 months
- Esophageal stricture or gross esophageal anatomic abnormalities (Schatzki’s ring, obstructive lesions, etc.)
- Esophageal 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 esophagus does not relax), bleeding, death, device erosion (device passing through the esophageal 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 esophagus, 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.
(145680-200706 EMEA)
Manufactured by:
Torax Medical, Inc.
4188 Lexington Avenue North
Shoreview, Minnesota 55126, USA