LINX is an effective option to treat GERD after sleeve gastrectomy

LINX is an effective option to treat GERD after sleeve gastrectomy

Many patients continue to experience GERD after undergoing laparoscopic sleeve gastrectomy (LSG), and in some cases, may even develop GERD symptoms post-sleeve.1-3 A one-year clinical trial evaluated the safety and efficacy of the LINX Reflux Management System in patients with GERD who have had a prior LSG procedure. LINX provides ongoing GERD relief4*, and is an antireflux treatment option for post-sleeve patients.

Many patients continue to experience GERD after undergoing laparoscopic sleeve gastrectomy (LSG), and in some cases, may even develop GERD symptoms post-sleeve.1-3 A one-year clinical trial evaluated the safety and efficacy of the LINX Reflux Management System in patients with GERD who have had a prior LSG procedure. LINX provides ongoing GERD relief4*, and is an antireflux treatment option for post-sleeve patients.

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Results of a clinical trial of LINX in patients with persistent GERD following sleeve gastrectomy (n=30):5

85%

no longer needed daily PPIs one year after LINX treatment#

81%

were free from moderate-to-severe heartburn at one year6†

92%

were free from moderate-to-severe regurgitation at one year

Post-Sleeve Study Published

Post-Sleeve Study Published

A study (Khaitan et al.) assessing the safety and efficacy outcomes of LINX after laparoscopic sleeve gastrectomy (LSG) has been published in Obesity Surgery. This study followed 30 patients for 12 months post-LINX implantation and measured distal acid exposure, GERD-HRQL, and average daily PPI use compared to baseline.
 

One year safety results

No migrations. No erosions. 

No device migrations or erosions were observed within 12 months post-implant.5†

Low removal rate. 

6.7% device explant rate one year after LINX treatment.5**

Dysphagia resolved within 12 months post-op.

All patients completing the study were free from dysphagia at 12 months post-LINX implantation.7††

Improved quality of life

Improved quality of life

81% of patients reported a ≥50% improvement in total GERD-HRQL score from baseline to 12 months post-LINX implantation.

LINX also preserved physiologic function, with 92% of patients able to vomit (if needed) at one year, and 96% of patients reporting the ability to belch one year after LINX treatment.5†

Additional Resources

Post-Sleeve Full Text Article

Results from the RELIEF Trial

Post-Sleeve Results Brochure

Patient Post-Sleeve Brochure

Identifying candidates for LINX™ treatment

Identifying candidates for LINX treatment

LINX may be a treatment option for GERD patients who exhibit some, or all, of the following:

  • Symptomatic while on PPIs
  • Quality of life significantly affected by GERD
  • Concerned about long-term medication use
  • PPIs contraindicated
  • Uncontrolled regurgitation

References

* Based on 5-year follow-up of 84 patients implanted with LINX (n=100 at baseline). 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).

# 15.4% (4/26) of patients implanted with LINX, after laparoscopic sleeve gastrectomy, were on PPIs at 12 months vs. 100% at baseline.

† Based on Foregut Symptom Questionnaire responses at 12 months (n=26) of patients implanted with LINX after laparoscopic sleeve gastrectomy.

‡ 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.

§ 15.4% (4/26) of patients implanted with LINX, after laparoscopic sleeve gastrectomy, experienced extra-esophageal symptoms at 1 year vs. 40% (12/30) at baseline

¶ 80.8% (21/26) of patients implanted with LINX, after laparoscopic sleeve gastrectomy, reported ≥50% reduction from baseline to 12-month follow-up (p<0.001)

** Patients were implanted with LINX after laparoscopic sleeve gastrectomy. One explant occurred due to dysphagia, the other explant was deemed not product/procedure related

†† 12-month follow-up (n=27) of patients implanted with LINX after laparoscopic sleeve gastrectomy. 5 patients experienced dysphagia postoperatively, but all had resolved by 12 months.

1.        Jain-Spangler K, Chumakova-Orin M. Interventions for the management of post-sleeve GERD. Dig Dis Interv. 2021;5(3):222-228.

2.    Bolckmans R, Roriz-Silva R, Mazzini GS, et al. Long-term implications of GERD after sleeve gastrectomy. Curr Surg Rep. 2021;9(7):epub

3.    DuPree CE, Blair K, Steele SR, Martin MJ. Laparoscopic sleeve gastrectomy in patients with preexisting gastroesophageal reflux disease: A national analysis. JAMA Surgery. 2014;149(4):328-334.

4.    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

5.    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.

6.    The LINX Reflux Management System IDE Study Table 17b, Foregut Symptoms Questionnaire by Visit (Off PPI). Ethicon Inc., Internal Report. October 14, 2021.

7.        The LINX Reflux Management System IDE Study Table. Number of Subjects with Unresolved Dysphagia at Key Study Timepoints, Full Analysis Set. Ethicon Inc., Internal Report. May 11, 2022.

8.    Katz PO, Dunbar K, Schnoll-Sussman FH, Greer KB, Yadlapati R, Spechler SJ. ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease. Amer J Gastroenterol. 2022;117(1):27-56.

 

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 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 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). 

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