LINX™ Reflux Management System
LINX™ Reflux Management System
The LINX Reflux Management System is a laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD). LINX™ is a flexible ring of small magnets placed around the lower esophageal sphincter (LES)—the strength of the magnets is precisely calibrated to help keep the weak LES closed to prevent reflux.
IMAGES
An innovative surgical treatment for GERD clinically shown to produce consistent, lasting results.1-3*
99%
of patients reported no regurgitation 5 years after LINX™ treatment1†
88%
of patients reported no bothersome heartburn after 5 years.1‡
85%
of patients no longer needed PPIs after LINX™ treatment.1§
83%
A 50% or greater reduction in GERD-HRQL score was achieved in 83% of patients.1¶
Features & Benefits
A revolutionary treatment for reflux disease
LINX™ augments the weak sphincter without compressing the esophagus. The dynamic opening and closing of the beads preserves physiological function, allowing patients to belch and vomit.3#
Long-term efficacy
In a long‐term follow‐up study, 89% of LINX patients at a median of 9 years post‐op met criteria for favorable long‐term outcomes4**
Favorable safety profile
With a low rate of device removals, rare occurrence of device erosions and no migrations seen in clinical trials, the clinical evidence supports LINX as an effective treatment for GERD with a favorable safety profile.1††
Supported by gastroenterological societies
Recent guidelines/practice updates from the ACG and AGA include LINX™ as an effective surgical option for patients with evidence of GERD.5,6
LINX™ is an effective option to treat GERD after Sleeve Gastrectomy
One-year results of a clinical trial of LINX™ in patients with persistent GERD following sleeve gastrectomy include:7
85%
were free from daily PPIs‡‡
81%
were free from moderate-to-severe heartburn8//
92%
were free from moderate-to-severe regurgitation§§
85%
were free from extra-esophageal symptoms¥
LINX™ Improved Quality of Life
A one-year clinical trial evaluated the safety and efficacy of LINX™ in patients who have had prior a laparoscopic sleeve gastrectomy (LSG) procedure. 81% of LINX™ patients reported improved quality of life 12 months after treatment.7## Additionally, no device migrations or erosions were observed within 12 months of LINX™ treatment.7¥¥
Additional Resources
MR conditional
Patients with a LINX™ device can undergo a wide range of diagnostic imaging tests, including: X-Ray, ultrasound, PET scan, CT scan, and MRI under certain conditions.9
Updated sizing tool
The LINX Reflux Management System Esophagus Sizing Tool is designed to enable one-handed use and sizing confidence.
Supporting Documentation
References
* Individual results may vary
† 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)
‡ Based on a 100 patient, 5 year, prospective, multi‐center, single‐arm study of 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, daily use of PPIs was 100% at baseline and decreased to 15.3% 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, the success criteria for quality of life (50% reduction in total GERD-HRQL score and 50% reduction in PPI use) were met.
# 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).
** Based upon a 6‐12 years follow up study of 124 patients. Favorable outcomes were defined as ≥ 50% improvement in GERD‐ HRQL total score and PPI discontinuation
†† 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.
‡‡ 15.4% (4/26) of patients implanted with LINX, after laparoscopic sleeve gastrectomy, were on PPIs at 12 months vs. 100% at baseline.
// Based on Foregut Symptom Questionnaire responses at 12 months (n=26) of patients implanted with LINX after laparoscopic sleeve gastrectomy.
§§ 7.7% (2/26) of patients implanted with LINX, after laparoscopic sleeve gastrectomy, had moderate-to-severe regurgitation at 1 year vs. 80% (24/30) at baseline.
¥ 15.4% (4/26) of patients implanted with LINX, after laparoscopic sleeve gastrectomy, experienced extra-esophageal symptoms at 1 year vs. 40% (12/30) at baseline
## 80.8% (21/26) of patients implanted with LINX, after laparoscopic sleeve gastrectomy, reported ≥50% reduction in GERD-HRQL from baseline to 12-month follow-up (p<0.001)
¥¥ Based on 12-month follow-up (n=26) of patients implanted with LINX after laparoscopic sleeve gastrectomy
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.
2. 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.
3. 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.
4. Ferrari D, Asti E, Lazzari V, et al. Six to 12‐year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease. Sci Rep. 2020. 10(13753).
5. Katz PO, Dunbar K, Schnoll-Sussman FH, Greer KB, Yadlapati R, Spechler SJ. ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease. Amer J Gastroenterol. 2022;117(1):27-56.
6. Yadlapati R, Gyawali CP, Pandolfino JE. AGA Clinical Practice Update on the Personalized Approach to the Evaluation and Management of GERD: Expert Review. Clinical Gastroenterology and Hepatology. 2022;20(5):984-994.e1
7. RELIEF Study: A Prospective, Multicenter Study of Refux Management with the LINX System for Gastroesophageal Refux Disease After Laparoscopic Sleeve Gastrectomy. Ethicon Inc., Internal Report. October 14, 2021.
8. The LINX Refux Management System IDE Study Table 17b, Foregut Symptoms Questionnaire by Visit (Of PPI). Ethicon Inc., Internal Report. October 14, 2021.
9. LINX Reflux Management System, Instructions for Use. Ethicon, Inc.
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.
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 with the exception of Laparoscopic Sleeve Gastrectomy (LSG) which has been evaluated for safety and efficacy.
- 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, swallow-Induced syncope (fainting), stomach bloating, ulcer, vomiting, weight loss, and worsening of preoperative symptoms (including but not limited to dysphagia or heartburn).
101161-221006 © Ethicon, US LLC 2022
Manufactured by:
Torax® Medical, Inc.
4188 Lexington Avenue North
Shoreview, Minnesota 55126, USA
©Ethicon, Inc. 2022. All rights reserved. 100324-220804
© Ethicon US, LLC. 2022.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
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Last updated February 20, 2019. The third-party trademarks used herein are trademarks of their respective owners. Data and usage fees may apply. See your carrier for more information.
