LINX™ Reflux Management System

A. Individual results may vary
B. Based on a 100 patient, 5 year, prospective, multi-center, single-arm study of patients who were implanted with LINX, regurgitation was 57% at baseline and decreased to 1.2% at 5 years (n=84). (p<0.001)
C. In 84 patients evaluated at 5 years (n=100 at baseline), bothersome heartburn decreased to 11.9% at 5 years from 89% (p<0.001) and PPI dependence decreased to 15.3% at 5 years from 100% (p<0.001)
D. 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).
E. Based on a 5 year prospective, multi-center, single-arm study observing 100 patients who were implanted with LINX, daily use of PPIs was 100% at baseline and decreased to 15.3% at 5 years. (p<0.001)
F. Based on a 100 patient, 5 year, prospective, multi-center, single-arm study of patients who were implanted with LINX, bothersome heartburn was 89% at baseline and decreased to 11.9% at 5 years (n=84). (p<0.001)
G. Based on a 5 year prospective, multi-center, single-arm study observing 100 patients who were implanted with LINX, symptoms of bloating/gas decreased from 52% at baseline to 8.3% at 5 years. (p<0.001)
H. 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).
I. The LINX Reflux Management System device consists of titanium beads with magnetic cores that are connected with independent titanium wires.
J. 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).
K. Based on a prospective study of the safety and efficacy of magnetic devices in 100 adults with GERD for 6 months or more, who were partially responsive to daily PPIs and had evidence of pathologic esophageal acid exposure, at 14 centers in the US and Netherlands. Three patients underwent uneventful Nissen fundoplication after LINX device removal.
L. Based on a prospective study of 100 adults who underwent MSA in which all patients reported the ability to belch and vomit (if necessary), and a retrospective matched-pair analysis of 1-year outcomes of 100 patients undergoing MSA and LNF from June 2010 to June 2013. After MSA 8.5% of patients were unable to belch compared to 25.5% of patients after LNF (p=0.028), and 4.3% of MSA patients were unable to vomit compared to 21.3% of LNF patients (p=0.004).
M. 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 39 minutes, respectively.
N. 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.
O. 95.8% (23/24) of patients implanted with LINX, after laparoscopic sleeve gastrectomy, reported ≥50% reduction from baseline to 12-month follow-up (p<0.001)
P. Based on Foregut Symptom Questionnaire responses at 12 months (n=26) of patients implanted with LINX after laparoscopic sleeve gastrectomy.
Q. 7.7% (2/26) of patients implanted with LINX, after laparoscopic sleeve gastrectomy, had moderate-to-severe regurgitation at 1 year vs. 80% (24/30) at baseline.
R. 80.8% (21/26) of patients implanted with LINX, after laparoscopic sleeve gastrectomy, reported ≥50% reduction in GERD-HRQL from baseline to 12-month follow-up (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. LINX™ Reflux Management System, Instructions for Use. Ethicon, Inc.
5. 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.
6. 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.
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.
8. RELIEF Study: A Prospective, Multicenter Study of Reflux Management with the LINX® System for Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy. Ethicon Inc., Internal Report. October 14, 2021.
9. The LINX Reflux Management System IDE Study Table 17b, Foregut Symptoms Questionnaire by Visit (Off PPI). Ethicon Inc., Internal Report. October 14, 2021.

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.

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 use of the LINX device has been evaluated and found to be safe and effective for the management of GERD symptoms in patients with Barrett’s Esophagus (BE). LINX has not been evaluated as a primary treatment for BE; patients with BE who are treated with LINX for management of GERD symptoms should consult with their physician for continued treatment of BE (including PPI use).

The safety and effectiveness of the LINX device has not been evaluated in patients with 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 with the exception of Laparoscopic Sleeve Gastrectomy (LSG) which has been evaluated for safety and efficacy.
• 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, swallow-induced syncope (fainting), stomach bloating, ulcer, vomiting, weight loss, and worsening of preoperative symptoms (including but not limited to dysphagia or heartburn).

Manufactured by:

Torax® Medical, Inc.

4545 Creek Rd

Cincinnati, OH 45242