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Don’t compromise… Get long-term GERD relief with LINX®1*
LINX® is not a pill. It’s a revolutionary treatment for GERD that is clinically shown to produce consistent, lasting results.1-3† After treatment with LINX®, 99% of patients no longer experienced regurgitation.1 Over 85% were free of heartburn—and no longer needed daily reflux medication!1‡ Just imagine what long-lasting GERD relief might be like for you.
How LINX® Works
LINX® is a small, flexible ring placed around the lower esophagus, right above the opening to the stomach. It keeps harmful stomach acid from flowing back up into the esophagus, where it can cause painful heartburn and damage. With LINX®, acid stays in the stomach, where it belongs. See a short video on how LINX® works.
A short outpatient procedure
LINX® is implanted during a minimally invasive, same-day procedure that is generally completed in less than one hour.4-6§ Patients typically go home within 24 hours, and most return to normal activities in just a few days.6¶ And, best of all, they can resume a regular diet.7
Imagine life after LINX®
Picture being free to live in the moment again, without worrying about GERD. After treatment with LINX®, patients reported a significant improvement in their quality of life.1¥ Watch their success stories and see what life can be like with GERD under control, long-term.
As with any medical treatment, individual results may vary. Consult a physician to determine if LINX® is a treatment option for you.
* 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).
† Individual results may vary
‡ Bothersome heartburn decreased to 11.9% at 5 years from 89%(p<0.001, n=100) and PPI dependence decreased to 15.3% at 5 years from 100% (p<0.001, n=100)
§ Median operative time for 67 patients was 60 minutes.4 Median operative time for 100 patients was 47 minutes.5 Median operative time for 100 patients was 39 minutes.6
¶ 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.
¥ 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).
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. 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.
5. 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.
6. LINX® Reflux Management System 1.5T, Instructions for Use.
7. 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.
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.
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:
• 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).
Torax® Medical, Inc.
4188 Lexington Avenue North
Shoreview, Minnesota 55126, USA