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LINX® FAQs
How is LINX® implanted?
LINX® is implanted using a surgical technique called laparoscopy. This technique uses small incisions in the abdominal wall to access the area around the esophagus where the device will be placed.
When can I start eating normally again?
Patients are encouraged to return to a regular diet as quickly as can be tolerated. This helps the body adapt to LINX®.
When can I return to normal physical activities?
Patients are generally able to return to nonstrenuous activity within a couple of days.
Will I be able to belch or vomit with LINX®?
LINX® preserves normal physiological function so you can belch or vomit as needed.1 The titanium beads open and close to let food down, and if it needs to come up, it can.
How long will LINX® last?
LINX® has been designed to last long term. It is constructed from materials commonly used in other medical implants.3
Can I go through airport security?
LINX® is designed for everyday life. The device will not affect airport security measures. You’re good to go with LINX®.
Can I have an MRI?
There are two versions of the LINX® device. One is safe in MRI scanning machines up to 0.7T, the other is safe up to 1.5T. You should discuss the MRI scanning options with your doctor prior to deciding on treatment with the LINX® system. Additional MRI Information.
Can LINX® be removed?
Yes. LINX® can be removed through a minimally invasive procedure and preserves future treatment options for patients.
At what age can I have the LINX® procedure?
Anti-reflux surgery with LINX® is indicated for people over 21 years.
How much does it cost to get LINX®?
We suggest consulting the value of surgery and the device in institutions with surgeons certified to operate with LINX® based on testing that qualifies candidates for surgery.
I have a Hiatal Hernia, can I have the operation?
It is possible to have the operation with LINX® if you have a hiatal hernia and it is corrected during minimally invasive surgery. See the important safety information for additional information on risks and warnings.
How long is the operation?
Minimally invasive anti-reflux surgery with LINX® is generally completed in less than one hour.2
How do I know if I am a candidate?
We suggest consulting a specialist who with more testing may or may not recommend surgery with LINX®.
Are there any risks?
Like all surgery there are associated risks, these may depend on multiple factors, we suggest conversations with a certified LINX® surgeon and thus resolve these and more questions.
References
1. 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).
2. 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.
3. The LINX device consists of titanium beads with magnetic cores that are connected with independent titanium wires.
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