LINX® Reflux Management System

An innovative surgical treatment for GERD clinically shown to produce consistent, lasting results1*

*Individual results may vary

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MULTI-DIRECTIONALLOCKING CLASP

TITANIUM BEADS

MAGNETIC CORES

INDEPENDENTTITANIUM

WIRES

LINX®

Esophagus

Stomach

Acid

Esophagus

Stomach

LINX®

Food

Acid

LINX® System15-25 mm Hg

NormalPeristalticPressures

35-80mm Hg

GastricPressures

5-10mm Hg

Benefits of LINX Reflux Management System:

• Augments weak sphincter without compressing esophagus

• Preserves ability to belch and vomit (5-year data)3

• LINX Reflux Management System vs Nissen fundoplication

– No alteration to stomach anatomy

– Fewer unfavorable side effects4

– Preserves future options; patients can undergo subsequent fundoplication after device removal5

• Patients can undergo a wide range of imaging tests, including MRI (up to 1.5T)6

LINX Reflux Management System is designed to work in harmony with the body to augment the weak sphincter without compressing the esophagus. The strength of

the magnets is calibrated to restore the LES barrier function.

LINX Reflux Management System mechanism of action: dynamic augmentation

Restore the barrier, control the reflux2

LINX Reflux Management System is a flexible ring of small magnets placed around the LES during a minimally invasive procedure.

LINX Reflux Management System consists

of a series of titanium beads with magnetic

cores that are connected with independent

titanium wires. The attractive force of the

magnetic beads is designed to provide

additional strength to keep a weak lower

esophageal sphincter (LES) closed, thus

restoring the reflux barrier.

During swallowing, the magnetic beads slide

away from each other on the independent

titanium wires to allow esophageal

distention as food passes.

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LINX Reflux Management System: Consistent symptom improvement results and sustained improvement in quality of life at 5 years1,7

Consistent symptom improvement across multiple studies15-year study: Sustained long-term results

Baseline(n=100)

% o

f Pat

ien

ts%

of P

atie

nts

% o

f Pat

ien

ts

Year 1(n=95)

Year 2(N=90)

Year 3(N=87)

Year 4(N=86)

Year 5(N=84)

25%

20%

15%

10%

5%

0%

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

100%

80%

60%

40%

20%

0%

Heartburn

Regurgitation

PPI Dependence

Dissatisfaction

Pre-LINX® Post-LINX®

5-year results showed:• Durable resolution of bothersome heartburn8

• Durable reduction in PPI usage9

• Durable resolution of regurgitation10

• Sustained improvement in quality of life7

Baseline(n=100)

% o

f Pat

ien

ts%

of P

atie

nts

% o

f Pat

ien

ts

Year 1(n=95)

Year 2(N=90)

Year 3(N=87)

Year 4(N=86)

Year 5(N=84)

25%

20%

15%

10%

5%

0%

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

100%

80%

60%

40%

20%

0%

Saino et al. (5 Yr)

Riegler et al. (1 Yr)

Smith et al. (6M)

Ganz et al. (5 Yr)

Reynolds et al. (1 Yr)

Warren et al. (1 Yr)

Bonavina et al. (3 Yr)

Louie et al. (6M)

PPI Use

Pre-LINX® Post-LINX®

PPI=proton pump inhibitor

Baseline(n=100)

% o

f Pat

ien

ts%

of P

atie

nts

% o

f Pat

ien

ts

Year 1(n=95)

Year 2(N=90)

Year 3(N=87)

Year 4(N=86)

Year 5(N=84)

25%

20%

15%

10%

5%

0%

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

100%

80%

60%

40%

20%

0%

Saino et al. (5 Yr)

Riegler et al. (1 Yr)

Smith et al. (6M)

Ganz et al. (5 Yr)

Reynolds et al. (1 Yr)

Warren et al. (1 Yr)

Bonavina et al. (3 Yr)

Louie et al. (6M)

GERD-HRQL Score*

*HRQL=health-related quality of life. A decrease in GERD-HRQL score indicates an improvement in patient quality of life.

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More effective than twice-daily omeprazole in normalizing reflux11

In a randomized controlled trial, 91% of LINX Reflux Management System patients returned to normal reflux episodes at 6 months compared to only 58% of PPI patients11

9 out of 10 patients achieved freedom from dependence on daily PPI use within 6 months after treatment with LINX Reflux Management System12

LINX Reflux Management System is an option for GERD patients with hiatal hernias—regardless of hernia size13

LINX Reflux Management System evidence for patients with large hiatal hernias (≥3 cm)13:

• Significantly improved quality of life (GERD-HRQL scores)

• Reduction in PPI usage

• Symptom improvement or resolution in 98% of patients

95% of patients with large hiatal hernias (≥3 cm) who had hernia repair surgery plus LINX Reflux Management System implantation were free from hernia recurrence at 18 months post-op.14

Improvement in regurgitation, quality of life, and satisfaction

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%Relief from

Regurgitation

89%

10%

81%

8%

2%

81%

Improvement in GERD-HRQL Score

Satisfaction with Current Condition

% o

f Pat

ien

ts

LINX®

BID PPI

Similar outcomes for patients with large and small hiatal hernias13

EFFICACY IN HIATAL HERNIAS

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%Postoperative

PPI Use

26.6%

9.6%

91.3%

98.1%

Symptom Improvement or Resolution

13.5%

17.9%

Dysphagia Requiring Dilation

% o

f Pat

ien

tsHiatal Hernia <3 cm

Hiatal Hernia ≥3 cm*

*Use of the LINX® device in patients with a hernia ≥3 cm should include hiatal hernia repair.

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To learn more or find a local LINX® surgeon, visit linxforlife.com

Testing required for LINX Reflux Management System

Endoscopy

pH

Manometry

LINX Reflux Management System had a favorable safety profile and low incidence of side effects4,15

Safety results through 4 years16

n=3,283 patients

SAFETY EXPERIENCE OCCURRENCE RATE

Device removal 2.7%

Device erosion 0.15%

Device migration 0.0%

CLINICAL TRIAL DATA

Low incidence of side effects4*

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%Di�iculty Swallowing Bloating/Gassy Nausea/Vomiting

% o

f Pat

ien

ts

Baseline

LINX® Year 5

*Side effects commonly associated with Nissen fundoplication are largely absent with LINX®

LINX Reflux Management System may benefit symptomatic patients who are seeking an alternative to continuous acid suppression therapy:

• Symptomatic while on PPIs

• Quality of life significantly affected by GERD

• Concerned about long-term medication use

• PPIs contraindicated

• Uncontrolled regurgitation

Consider LINX Reflux Management System for your appropriate patients with GERD

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© 2020 Ethicon US, LLC. All rights reserved. 122688-200330

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.

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 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).

References: 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. 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. 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. 2. 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). 3. 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. Based on a prospective study in which 85 out of 100 adults were available for 5-year follow-up after MSA; all patients reported the ability to belch and vomit (if necessary). 4. 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. 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). 5. 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 esoph-ageal acid exposure, at 14 centers in the US and Netherlands. Three patients underwent uneventful Nissen fundoplication after LINX device removal. 6. This device can be scanned safely under the following conditions: 1) 1.5-Tesla static magnetic field, 2) maximum spatial gradient field of 17.15 T/cm, 3) maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4.0 W/kg in First Level Controlled Operating Mode, and 4) the patient may feel pressure around the lower esophagus; should the patient experience pain, immediately discontinue the scan and remove the patient from the MR environment. 7. 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. Based on a 5 year prospective, multi-center, single-arm study observing 100 patients who were implanted with LINX, there was a significant improve-ment 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). 8. 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). 9. 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. 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). 10. 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. 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). 11. Based on a RCT comparing patients on twice-daily PPI (BID PPI) to patients treated with laparoscopic MSA who all underwent impedance-pH testing. 91% of MSA patients vs. 58% of BID PPI patients had a normal number of reflux episodes at 6 months (p<0.001). Bell R, Lipham J, Louie B, et al. Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: A randomized controlled trial. 2018. Gastrointestinal Endoscopy. 12. Based on 47 patients treated with laparoscopic MSA. 91% of patients discontinued PPI use at 6 months. Bell R, Lipham J, Louie B, et al. Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: A randomized controlled trial. 2018. Gastrointestinal Endoscopy. 13. 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. Based on analysis of 192 patients who underwent MSA with LINX between May 2009 and December 2015. The rate of symptom improvement (98.1 vs. 91.3&, p=0.118) and dysphagia requiring intervention (13.5 vs. 17.9 % p=0.522) were similar for patients with large hiatal hernias ( > 3cm) and patients with small hiatal hernias (< 3 cm), respectively. Hiatal hernias larger than 3 cm require repair prior to device implant. 14. 2 of 47 patients had recurrent hiatal hernias at mean of 18 months after initial operation. 15. 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. Based on a prospective study of the safety and efficacy of magnetic devices in 100 adults. No device erosions, migrations, or malfunctions occurred in this study. Device removal occurred in 7 patients. 16. Smith C, Ganz R, Lipham J, et al. Lower Esophageal Sphincter Augmentation for Gastroesophageal Reflux Disease: The Safety of a Modern Implant. J Laparoendosc Adv Surg Tech. 2017. 27(6):586-591.

Torax® Medical, Inc. 4188 Lexington Avenue North

Manufactured by: Shoreview, Minnesota 55126, USA www.linxforlife.com

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