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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 oesophagus 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.1,2*
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.3,4† 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.5,6‡
Can I have an MRI?
There are two versions of the LINX device. 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.4
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 less than 3cm 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?
LINX is implanted during a minimally invasive procedure, which is usually same-day and completed in less than one hour.7-9§
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.
* As dictated by your healthcare professional
† 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).
‡ 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.
§ 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.
1. 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.
2. 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.
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;221:123-128.
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;14:671-677
5. As per Instructions for Use
6. International Titanium Association. Medical Technology. Available from https://titanium.org/page/MedicalTechnology [Accessed 03 Nov 2020]
7. 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.
8. 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.
9. Ganz R, Peters J, Horgan S, et al. Esophageal Sphincter Device for Gastroesophageal Reflux Disease. N Engl J Med. 2013. 368(8):719-727.
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 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 oesophagus 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:
- 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