LINX^® Reflux Management System

* Based on a 5-year 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), bothersome regurgitation was 57% at baseline and decreased to 1.2% at 5 years (p<0.001), PPI dependence 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, 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 Refux. Clin Gastroenterol
Hepatol. 2016. 14(5):671-7.

2. Rona K, Reynolds J, Schwameis K, et al. Efcacy 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. 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).

5. 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)

6. 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)

7. 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)

8. 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 GERDHRQL score, and PPI use 50% reduction) were met.

9. 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.

10. 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).

11. 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).

12. LINX^® Reflux Management System, Instructions for Use. Ethicon, Inc.

LINX^® Refux Management System Important Safety Information

The LINX^® Refux Management System is a laparoscopic, fundic-sparing anti-refux procedure indicated for patients diagnosed with Gastroesophageal Refux Disease (GERD) as defned 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 Refux 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 antireflux 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 Difuse 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).

For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.

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