* Evaluation of GORD-HRQL scores 1 year after treatment. 41 of 44 (93%) LINX patients achieved ≥50% change from baseline GORD-HRQL scores, (p <0.001). No improvement was seen in the PPI cohort in GORD-HRQL.

† Evaluation of symptoms 1 year after treatment. 43 of 44 (98%) LINX patients reported control of regurgitation vs. 8 of 43 (19%) PPI patients, p < 0.001

‡ LINX was associated with discontinuation of PPI in 68 of 75 (91%) patients after implantation at study completion

§ Demeester scores were normalized in 70% (n=48 of 69) of LINX patients at 12 months post-implantation. Median Demeester scores for LINX patients improved from 40.5 (IQR, 25.7-49.5) to 5.3 (IQR, 1.2-18.5) at 12 months post-implantation

¶ The surgical technique does not require active alteration of the stomach anatomy

β 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).

€ 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/m, 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. Patients implanted with LINX prior to May 22, 2015, have been implanted with the 0.7T device and cannot undergo testing in a magnetic resonance imaging (MRI) system above 0.7T. Refer to IFU for warnings/MRI safety information

\\ Based on physical benchtop testing

¥ Based upon a 6-12 years follow up study of 124 patients. Median years of patient follow up was 9 years, indicating that not all patients had reached 12 years post-op.

$ Long term results based on 32 patients

Ω 9.4% of patients still used daily PPIs at >10-year follow-up (n=32)

II 3 device removals observed in 6-12-year follow-up for heartburn, dysphagia, and need of magnetic resonance study (n=124)

** 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).

†† 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 36 minutes, respectively.

‡‡ 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 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)

ββ Based on a study observing 100 patients who were implanted with LINX, daily use of PPIs decreased to 15.3% at 5 years. 84.7% were either completely off PPIs or reported use as needed at 5 years after surgery. (p<0.001)

€€ Based on a 5-year prospective, multi-center, single-arm study observing 100 patients who were implanted with LINX, moderate to severe 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. 84 subjects were followed up for 5 years. 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). Baseline dissatisfaction was 95% and decreased to 7.1% in year 5 (p<.001), based on the GERD-HRQL.

ΩΩ Based on a prospective, multi-center, single-arm study in which 85 out of 100 adults were available for 5-year follow-up after MSA with LINX, the success criteria for quality of life (50% reduction in total GERD-HRQL score, 70 of 84 patients) was met.

*** Based on a prospective, multi-center, single-arm study in which 85 out of 100 adults were available for 5-year follow-up after MSA with LINX, the success criteria for PPI use (50% reduction, 76 of 85 patients) was met.

††† Regurgitation and heartburn scores in PPI non-responders improved from 3.6 to 0.5 and 20 to 3, respectively, from baseline to 12-months post-LINX treatment

‡‡‡ 89% of patients who completed esophageal pH monitoring at 6-12-year follow-up achieved normal esophageal acid exposure or at least a 50% reduction compared to baseline (n=91)

§§§ Complete cessation of daily dose PPIs observed in 79% of patients at 9-year median follow up (6-12 years post LINX implantation, n=124)

¶¶¶ Based upon a 6-12 years follow up study of 124 patients. Favorable outcomes were defined as ≥ 50% improvement in GERD-HRQL total score and PPI discontinuation

1. Bell R, Lipham J, Louie B, et al. Magnetic sphincter augmentation superior to proton pump inhibitors for regurgitation in a 1-year randomized trial. Clin Gastroenterol Hepatol. 2020;18:1736-1743

2. Bonavina L, Saino GI, Bona D et al. Magnetic augmentation of the lower esophageal sphincter: results of a feasibility clinical trial. J Gastrointest Surg. 2008 ;12(12):2133-40. 

3. Asti E, Bonitta G, Lovece A, Lazzari V, Bonavina L. Longitudinal comparison of quality of life in patients undergoing laparoscopic Toupet fundoplication versus magnetic sphincter augmentation: Observational cohort study with propensity score analysis. Medicine (Baltimore). 2016 ;95(30):e4366.

4. Bonavina L, DeMeester TR, Ganz RA. LINX Reflux Management System: magnetic sphincter augmentation in the treatment of gastroesophageal reflux disease. Expert Rev Gastroenterol Hepatol. 2012;6(6):667-674.

5. 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. 

6. 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.

7. Ethicon, DR000589J Viking Quality Record, Aug 2019, Data on file Ethicon, PRC089499A Project Viking Design Verification Completion Report, Feb 2020 Ethicon, PRC091364A Design Validation Completion Report, Aug 2019, Data on file (173512-210412 EMEA)

8. Ethicon, PRC089499A Project Viking Design Verification Completion Report, Feb 2020 (173509-210412 EMEA)

9. Ethicon, DR000589J Viking Quality Record, Aug 2019, Data on file Ethicon, PRC091364A Design Validation Completion Report, Aug 2019, Data on file (173510-210412 EMEA)

10. Ferrari D, Asti E, Lazzari V, et al. Six to 12-year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease. Sci Rep. 2020;10:13753.

11. 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. 

12. 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. 

13. Ganz R, Peters J, Horgan S, et al. Esophageal Sphincter Device for Gastroesophageal Reflux Disease. N Engl J Med. 2013. 368(8): 719-727.

14. 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. 

Indications, Safety and Warnings

The LINX Reflux Management System is indicated for patients diagnosed with pathologic Gastro-oesophageal Reflux Disease (GORD) as defined by abnormal pH testing, and who continue to have chronic GORD 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 oesophagus or Grade C or D (LA classification) or Grade IV (Savary-Miller) oesophagitis.

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 oesophageal or gastric cancer 
• Prior oesophageal or gastric surgery or endoscopic intervention 
• Distal oesophageal motility less than 35 mmHg peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences or a known motility disorder such as achalasia, nutcracker oesophagus, and diffuse oesophageal spasm or hypertensive LOS 
• Symptoms of dysphagia more than once per week within the last 3 months 
• Oesophageal stricture or gross oesophageal anatomic abnormalities (Schatzki’s ring, obstructive lesions, etc.) 
• Oesophageal 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 oesophagus does not relax), bleeding, death, device erosion (device passing through the oesophageal wall), device explant/re-operation, device failure, device migration (device does not appear to be at implant site), diarrhoea, dysphagia (difficulty swallowing), inability to belch or vomit, infection, impaired gastric motility, injury to the oesophagus, 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).
 

191313-211004 UK