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 are seeking an alternative to continuous acid suppression therapy.

LINX® Reflux  Management System

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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.

How LINX® Works

Control reflux, long term.1

Reduced medication.

Reduced medication.

85% of patients were free from dependence on daily reflux medication after treatment with LINX.2

Durable resolution of bothersome heartburn.

Durable resolution of bothersome heartburn.

88% of patients reported being free of heartburn five years after treatment with LINX.3

Durable resolution of regurgitation.

Durable resolution of regurgitation.

LINX eliminated regurgitation in 99% of patients.4

Significant decrease in gassiness and bloating.

Significant decrease in gassiness and bloating.

Patients reported significant improvement in gassiness and bloating after treatment with LINX.5

Improved quality of life.

Improved quality of life.

Patients reported significant improvement in their quality of life after surgical treatment with LINX.6

A revolutionary treatment for reflux disease

Simply designed to be simple.

Simply designed to be simple.

This quarter-sized device does exactly what your failing LES is supposed to do — prevent stomach acid from entering your esophagus.

Learn about the LINX procedure.

Learn about the LINX procedure.

The LINX procedure is generally completed is less than one hour.7 Most patients have same-day surgery or go home within 24 hours and return to normal activities in a few days.8 Patients treated with LINX can resume a regular diet.9

Talk to your doctor about LINX®

Talk to your doctor about LINX®

It’s time to start your journey and take back control. LINX® is intended for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy. Are you concerned with a lifetime of medication, pharmacy visits and potential side effects? If this sounds like you, talk to your doctor, it may be time for LINX®.

Demonstrated efficacy with a favorable safety profile.10

An inside look.

An inside look.

Designed to last long term. LINX® is constructed from materials commonly used in other medical implants* and is MRI compatible.11

Restore, don’t reconstruct.12

Restore, don’t reconstruct.12

Unlike other surgical treatments for GERD, LINX does not require changes to the stomach anatomy. If necessary, LINX can be removed using a minimally invasive procedure and preserves future treatment options for patients.13

Retained ability to belch and vomit.

Retained ability to belch and vomit.14

LINX® preserves physiological function to belch and vomit.15 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

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

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 (LES). Studies have shown that up to 40% of patients continue to have symptoms while on medication.16

Traditional Anti-Reflux Surgery: Fundoplication

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.17

Patient Success Stories

More Stories

LINX Wayne's Story
LINX Wayne's Story
03:05
LINX Jodi's Story
LINX Jodi's Story
04:14
LINX Ron's Story
LINX Ron's Story
04:18
LINX Tricia's Story
LINX Tricia's Story
04:02

Additional Resources

Frequently Asked Questions

Frequently Asked Questions

It is okay to have questions about LINX. See common questions and concerns that other patients have. 

MRI Information

MRI Information

LINX will not affect airport security, and is MRI compatible.11

Patient Information Booklet

Patient Information Booklet

Learn more about the LINX Reflux Management System, its risks, benefits, treatment process, and more. 

References

* The LINX device consists of titanium beads with magnetic cores that are connected with independent titanium wires

† As of January 28, 2020.

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(5):671-7. 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).

2. 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(5):671-7. Based on a study observing 100 patients who were implanted with LINX, daily use of PPIs  decreased to 15.3% at 5 years. (p<0.001)

3. 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(5):671-7. 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)

4. 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(5):671-7. Based on a 5 year prospective, multi-center, single-arm study observing 100 patients who were implanted with LINX, regurgitation was 57% at baseline and decreased to 1.2% at 5 years. (p<0.001)

5. 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(5):671-7. 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)

6. 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(5):671-7. 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).

7. 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(4): 577-85. Median operative time for 67 patients was 60 minutes. 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(10): 1034-38. Median operative time for 100 patients was 47 minutes. LINX® Reflux Management System, Instructions for Use. Median operative time for 100 patients was 39 minutes. 

8. Based on a pivotal IDE trial of 100 subjects at 14 clinical sites. Half of the subjects (50/100) were discharged the same day as the surgery, and the other half were discharged the next day. 

9. Ayazi S, Zheng P, Zaidi AH, et al. Magnetic sphincter augmentation and postoperative dysphagia: Characterization, clinical risk factors, and management. J Gastrointest Surg. 2020;24(1):39-49.

10. 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(5):671-7. Based on a prospective study of the safety and efficacy of magnetic devices in 100 adults. No device erosions, migrations, or malfunctions occurred in this study. Device removal occurred in 7 patients. 

11. 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/cm, 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

12. Based on a 5-year tudy 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), bothersome regurgitation was 57% at baseline and decreased to 1.2% at 5 years (p<0.001), PPI dependence decreased to 15.3% at 5 years (p<0.001).

13. Based on a prospective study of the safety and efficacy of magnetic devices in 100 adults with GERD for 6 months or more, who were partially responsive to daily PPIs and had evidence of pathologic esophageal acid exposure, at 14 centers in the US and Netherlands. Three patients underwent uneventful Nissen fundoplication after LINX device removal. 

14. 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(5):671-7. 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(1):123-128.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).

15. 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(1):123-128. 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).

16. Rona K, Reynolds J, Schwameis K, et al. Efficacy of magnetic sphincter augmentation in patients with large hiatal hernias. Surgical Endoscopy. 2017. 31(5):2096-2102.

17. 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(1):123-128.

LINX® Reflux Management System Important Safety Information 

The LINX® Reflux Management System is a laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD. 

Rx 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. It is recommended that patients receiving the LINX device register their implant with the MedicAlert Foundation (www.medicalert.org) or equivalent organization.  
Failure to secure the LINX device properly may result in its subsequent displacement and necessitate a second operation.  
Laparoscopic placement of the LINX device is major surgery and death can occur.  

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 explantation and/or replacement. 
The use of the LINX device in patients with a hiatal hernia larger than 3 cm should include hiatal hernia repair to reduce the hernia to less than 3 cm. The LINX device has not been evaluated in patients with an unrepaired hiatal hernia greater than 3 cm.  
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) 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 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 High Resolution Manometry equivalent, and/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) 
•    Age < 21 

Potential Side Effects: Potential adverse events associated with laparoscopic surgery and anesthesia include adverse reaction to anesthesia (headache, muscle pain, nausea), anaphylaxis (severe allergic reaction), cardiac arrest, death, diarrhea, fever, hypotension (low blood pressure), hypoxemia (low oxygen levels in the blood), infection, myocardial infarction, perforation, pneumonia, pulmonary embolism (blood clot in the lung), respiratory distress, and thrombophlebitis (blood clot). Other risks reported after anti-reflux surgery procedures include bloating, nausea, dysphagia (difficulty swallowing), odynophagia (painful swallowing), retching, and vomiting. 

Potential risks associated specifically with the LINX Reflux Management System include achalasia (lower part of esophagus does not relax), bleeding, cough, death, decreased appetite, device erosion, device explant/re-operation, device failure, device migration (device does not appear to be at implant site), diarrhea, dyspepsia (indigestion), dysphagia (difficulty swallowing), early satiety (feeling full after eating a small amount of food), esophageal spasms, esophageal stricture, flatulence, food impaction, globus sensation (sensation of a lump in the throat), hiccups, inability to belch or vomit, increased belching, 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, ulcer, vomiting, weight loss, and worsening of preoperative symptoms (including but not limited to dysphagia or heartburn). 

101161-181022  

Manufactured by:
Torax® Medical, Inc.
4188 Lexington Avenue North
Shoreview, Minnesota 55126, USA