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® Reflux Management System

Features & Benefits

  •  revolutionary treatment for reflux disease

    A revolutionary treatment for reflux disease

    Requires no permanent anatomic alteration to restore the reflux barrier. LINX™ is a flexible ring of small magnets placed around the LES during a minimally invasive procedure.  The strength of the magnets helps keep the LES closed to prevent reflux.   When patients swallow, LINX™ opens temporarily to allow food and liquid to pass into the stomach.

  • Consistent Results

    Consistent results1-3#

    88% of patients reported that bothersome heartburn had been eliminated 5 years after treatment with LINX™.1# 85% of patients were free from dependence on daily reflux medication after treatment with LINX.1† 99% of patients eliminated regurgitation at 5 years.1‡

  • Sustained Improvement in HRQL at 5 Years

    Sustained improvement in HRQL at 5 years 

    Patients reported significant improvement in quality of life after LINX. Achieved target reduction in GERD-HRQL score in 83% of patients, and target reduction in PPI usage in 89% of patients. Improvement in patient satisfaction at 5 years. The device maintains normal gastroesophageal junction and gastric anatomy and preserves physiologic function (belch and vomit). 3** Low incidence of side effects compared to Nissen fundoplication.3##

Product Resources

Resources

LINX EMEA Video Playlist
LINX Reflux Management System Design Video
0:01:38
LINX Reflux Management System Procedure - Dr Blaire A. Jobe, MD Video
0:05:28
LINX Reflux Management System Tissue Encapsulation Video
0:01:20
LINX Reflux Management System Short Procedure Video
0:02:15
Barium Swallow Video
0:01:33
LINX Reflux Management System Yield Pressure Video
0:01:36
Hiatal Hernia - Dr. John C. Lipham, MD
0:11:12

References

* Based on 192 patients who underwent MSA with LINX as well as a matched pair analysis in which 47 patients underwent MSA. 98.1% (p=0.118) and 97.8% of patients, respectively, reported symptom improvement or resolution. In a study of 100 patients implanted with LINX, bothersome heartburn decreased to 11.9% (p<0.001) and bothersome regurgitation decreased to 1.2% (p<0.001).

#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)

† 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)

‡ 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 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).

§ 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  PPI use 50% reduction) were met.

¶84 subjects were followed up for 5 years, baseline dissatisfaction was 95% and decreased to 7.1% in year 5 (p < .001). Based on the GERD-HRQL.

**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 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. There were no patients with severe gas and bloating in the MSA group compared with 10.6% in the LNF group (p=0.022). 8.5% of MSA patients were unable to belch, compared to 25.5% of LNF patients (p = 0.028). 4.3% of MSA patients were unable to vomit when necessary compared to 21.3% of LNF patients (p = 0.004).
 
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. 


Indications, Safety and Warnings

The LINX™ Reflux Management System is indicated for patients diagnosed with pathologic Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximum medical therapy.

The LINX Reflux Management System is labelled 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 esophagus 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:
    •    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 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) 

Potential Complications: Potential complications associated with the LINX Reflux Management System include achalasia (lower part of esophagus does not relax), bleeding, death, device erosion (device passing through the esophageal 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 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, 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.


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