TAVAC Safety and Effectiveness Analysis: LINX® Reflux Management System

Safety and Effectiveness Analysis
LINX® Reflux Management System
(Torax Medical, Inc.)

SAGES LINX SEA Committee

  • Chair: Jon Gould, MD
  • TAVAC Committee Chair: Dmitry Oleynikov, MD
  • David Rattner, MD
  • Nat Soper, MD
  • Vic Velanovich, MD

Technology Overview

The LINX® Reflux Management System (Torax Medical, Inc., Shoreview, MN, USA) is comprised of a small expandable ring of linked magnetic beads. The device is laparoscopically implanted around the esophagus at the esophagogastric junction to mechanically augment the function of the lower esophageal sphincter (LES) for the treatment of gastroesophageal reflux disease (GERD).

Each bead in the LINX device contains a neodymium iron boron magnetic core coated with biocompatible titanium. Sliding titanium wires connect each bead so that they can move independently, but they can’t completely separate. At rest, each bead is in contact with adjacent beads, minimizing compressive forces upon the esophagus. The magnetic attractive forces between each bead augment the pressure of the LES. At higher pressures, the magnetic forces are overcome and the ring expands to allow esophageal distention and the passage of a swallowed bolus or other physiologic functions, such as belching or vomiting.

The LINX Reflux Management System is based on the premise that a device placed around the LES can assist, or augment, an incompetent LES to maintain a closed position when challenged by gastric reflux. The LINX System is indicated for patients diagnosed with GERD as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite medical therapy for the treatment of reflux.

Compared to the current surgical standard for medically refractory GERD, a fundoplication, the LINX surgical procedure involves little dissection and fewer steps. This may potentially result in easier standardization, a shorter learning curve, and more consistent outcomes between different surgeons. Patients are started on a solid diet soon after the procedure, which is another difference from a patient perspective between LINX and fundoplication.

The LINX device implantation is performed laparoscopically under general anesthesia. The procedure uses standard laparoscopic ports, instruments and techniques. The device is placed at the end of the esophagus. Minimal dissection is required. A specialized sizing tool is used to measure the external esophageal circumference in the target area – allowing the surgeon to select the appropriately sized LINX device. An uncomplicated procedure can generally be performed in well under 1 hour.

The LINX System is not intended for use in patients with suspected or known allergies to metals such as iron, nickel, titanium, or stainless steel. After implantation, patients are ineligible to undergo magnetic resonance imaging because of the material in the implant. The LINX System is contraindicated in patients receiving electrical implants such as defibrillators or pacemakers or undergoing insertion of metallic implants in the abdomen. The LINX device is currently not recommended in patients with a hiatal hernia greater than 3-cm.

Development of the LINX device began in 2002. Animal testing of the current device began in 2005.1 An FDA approved Investigational Device Exemption (IDE) feasibility trial (#G060172) enrolled 44 patients at 4 sites in the US and Europe in 2007-2008. A 100 patient pivotal trial was subsequently performed at 14 US and European sites. Enrollment occurred throughout 2008-2009. Through 2011, 2-year follow-up on the pivotal trial was available. An FDA expert panel considered the clinical data from these 2 trials in January 2012, and pre-market approval (PMA #P100049) was granted in March 2012.2 The LINX system is labeled for use in GERD patients with abnormal pH testing who continue to have chronic symptoms despite anti-reflux therapy. The worldwide clinical experience is 497 magnetic implants with a median implant duration of 2.9 years (feasibility trial, pivotal trial, and commercial registries in the United States and Europe combined).

1. Technology Significance

Gastroesophageal reflux disease (GERD) is the most prevalent gastrointestinal disease in the United States. It is also one of the most important in terms of its chronicity, overall cost, adverse impact on quality of life, and potential for complications, such as Barrett’s esophagus and esophageal adenocarcinoma.3

Current estimates suggest that GERD affects around 10–20% of adults in Western countries on a daily or weekly basis.4 Up to 50% of patients with GERD may require chronic pharmacologic therapy.5 Long term GERD pharmacotherapy is exceedingly expensive with an estimated annual cost in the US of $11 billion.6 The most powerful and commonly prescribed acid suppression medications are proton pump inhibitors (PPIs). PPIs have been linked via retrospective studies to increased risk of enteric infections including Clostridium difficile-associated diarrhea, community-acquired pneumonia, bone fracture, nutritional deficiencies, and interference with metabolism of antiplatelet agents.7 It is estimated that as many as 40% of patients with GERD fail to respond symptomatically to aggressive acid suppression therapy.8,9,10 As a result, 20-40% of patients are dissatisfied with medical GERD treatment and see no viable alternative to more medications and persistent symptoms.11

Some patients with severe GERD and associated complications undergo antireflux surgery. Despite the fact that the prevalence of GERD has increased in recent years, utilization of laparoscopic Nissen fundoplication for medically refractory GERD has declined. With literally millions of American adults continuing to suffer from GERD symptoms despite aggressive medical therapy, an estimated 24,000 Americans underwent laparoscopic Nissen fundoplication in 2003.12 This accounts for less than 1% of patients estimated to be dissatisfied or who suffer from persistent symptoms on acid suppression medical therapy. This discrepancy is thought to be at least partly due to concerns over side effects associated with Nissen fundoplication (dysphagia, bloating) as well as the possibility of fundoplication failure with recurrent GERD and need for acid suppression medical therapy or repeat surgery.

Patients with GERD who have persistent symptoms on medical therapy who aren’t willing to consider traditional antireflux surgery (or are not referred to a surgeon to be considered) fall into what is known as the GERD treatment gap. The LINX system may be an attractive alternative to chronic medical therapy for GERD patients who are hesitant to undergo Nissen fundoplication. Following fundoplication, some patients describe difficulty belching and symptoms of bloating.13,14 Data from the premarket trial suggests that following the LINX procedure; most patients maintain their ability to belch and frequent/continuous bloating was reported at a low rate (5% of patients 12 months following LINX implantation described frequent or continuous bloating compared to 40% at baseline).15 Comparative outcomes data between fundoplication and the LINX procedure are needed.

Augmentation of the esophageal sphincter with a magnetic device may provide an alternative treatment for patients with incomplete symptom relief on acid suppression medical therapy or who are reluctant to undergo surgical fundoplication..

2. Current Clinical Practice and Alternatives

Mild to moderate cases of GERD are typically treated with lifestyle modifications, over-the-counter medications, and prescription drugs. Lifestyle changes include weight loss, avoiding certain foods, managing meal size and timing, and elevating the head of the bed. Continuous pharmacotherapy is a mainstay of GERD treatment.16 PPIs work by suppressing stomach acid production and subsequent reflux acidity. PPIs do not address the mechanism of regurgitation in patients with pathologic GERD. Central to the pathogenesis of GERD is a weak or incompetent LES that opens abnormally and allows the reflux of gastric contents into the esophagus.

In normal subjects, omeprazole treatment does not affect the number of reflux episodes or their duration; rather it converts acid reflux to less acid reflux, thus exposing esophagus to altered gastric juice. These observations may explain the persistence of symptoms and emergence of mucosal injury while on proton pump inhibitor therapy.17 Limitations of PPIs include the need for daily use, high cumulative costs, and decreased efficacy over time.

Surgical procedures are typically considered in patients with symptoms despite optimal PPI therapy and in patients with severe GERD. Surgery is used, however in less than 1% of eligible GERD patients, and its usage has been decreasing over the last decade.18 Laparoscopic Nissen fundoplication is the most commonly performed antireflux operation. The laparoscopic approach to fundoplication was introduced and popularized in the 1990’s. The surgical technique involves a complete hiatal dissection with mobilization of the esophagus and fundus, re-approximation of the diaphragmatic crura, and creation of a 360-degree wrap of fundus around the distal esophagus. Laparoscopic Nissen fundoplication can be accomplished in 2 hours or less for uncomplicated cases. Most patients stay in the hospital for 1-2 days. Many surgeons have their patients gradually transition from a soft or pureed diet to a more solid diet over the course of 2-8 weeks.19 Relief of symptoms, especially esophageal symptoms such as heartburn and regurgitation occurs in > 90% of patients and has been demonstrated to be durable beyond 10 years for the majority of patients.20,21 Potential surgical side effects following Nissen fundoplication include difficulty swallowing, increased flatus, bloating, early satiety, and inability to vomit or belch.22,23 Anatomic failure of the fundoplication with recurrent GERD can occur in 2-17% of cases.24 The published outcomes of antireflux surgery are not always replicated in the community, especially for surgeons who perform laparoscopic antireflux surgery infrequently.25,26 SAGES has published a Guidelines for Surgical Treatment of Gastroesophageal Reflux Disease. According to this document “The standardization of antireflux surgery technique is highly desirable, as it has been shown to lead to good postoperative patient outcomes (Grade A). Like any other surgical procedure, laparoscopic antireflux surgery is subject to a learning curve, which may impact patient outcomes. Therefore, surgeons with little experience in advanced laparoscopic techniques and fundoplication in particular should have expert supervision during their early experience with the procedure to minimize morbidity and improve patient outcomes (Grade B).”27 Concerns related to potential side effects, recurrent GERD, and repeat surgery following laparoscopic Nissen fundoplication likely play a role in the fact that most patients who meet indications for antireflux surgery never undergo this procedure.

As an alternative to laparoscopic antireflux surgery, there are a number of commercially available, FDA approved endoscopic incisionless procedures designed to treat GERD. An exhaustive review of these technologies is outside of the scope of this document. In general, the various endoscopic approaches to addressing GERD have been plagued by complications and a lack of long-term efficacy. A systematic review of endoscopic GERD treatments reviewed 33 studies involving 7 unique devices. The authors concluded that at the time of review, there was insufficient evidence to determine the safety and efficacy of endoscopic procedures for GERD, particularly in the long term.28 It is safe to say that despite more than a decade of experience with various endoscopic antireflux devices and treatments, a very small percentage of patients with GERD undergo an endoscopic procedures in current clinical practice. This likely relates to a variety of factors including a lack of proven long-term efficacy, safety concerns, and a lack of insurance benefits to cover the costs associated with the procedures.

3. Clinical Evidence Summary

Clinical studies involving the LINX system were identified via a search of the PubMed/Medline database (www.ncbi.nlm.nih.gov/pubmed) conducted in February 2013. The literature search used combinations of the keywords LINX, reflux, magnetic, and/or GERD. Review articles without unique clinical data were excluded. The bibliographies of key references were searched for relevant studies not uncovered in the PubMed search. The manufacturer’s website was also used to identify key references. Finally, summary reports for unpublished clinical data used in the approval process were identified on the FDA Web site. It is worth noting that the LINX patients in references 29-31 in the table below represent the same cohort at different intervals postoperatively (feasibility trial cohort). References 15 and 32 represent the same group of patients as well (pivotal trial cohort).

Citation

Study Type

Treatment(s)

Results

Author’s Conclusions

Lipham et al.29 (2012)Case series (n=44)LINX reflux management systemAt 3-year follow-up:
Average pH was reduced from 11.9 % to 3.8%.Normalization of the pH was reported in 18 patients.At 4-year follow-up:
Quality of life scores for GERD were improved in 23 patients. 20 patients discontinued use of PPIs. There were no reports of death or long-term device-related complications such as migration or erosion.
“Sphincter augmentation with the LINX Reflux Management System provided long-term clinical benefits with no safety issues, as demonstrated by reduced esophageal acid exposure, improved GERD-related quality of life, and cessation of dependence on PPIs, with minimal side effects and no safety issues. Patients with inadequate symptom control with acid suppression therapy may benefit from treatment with sphincter augmentation.”
Bonavina et al.30 (2010)Case series (n=44)LINX reflux management systemAt 1-year follow-up:
Gastroesophageal reflux disease (GERD) Health-Related Quality of life (HRQoL) scores improved from 25.7 to 3.8. Patient satisfaction was 87%. Average pH was reduced from 11.9% to 3.1%. 90% of patients discontinued use of proton pump inhibitors (PPIs). 77% of patients experienced normal esophageal exposure.2-year follow-up:
GERD HRQoL scores improved from 25.7 to 2.4. Patient satisfaction was 86%. Average pH was reduced from 11.9% to 2.4%. 86% of patients discontinued use of PPIs. 90% of patients experienced normal esophageal exposure.
“The new laparoscopically implanted sphincter augmentation device eliminates GERD symptoms without creating undue side effects and is effective at 1 and 2 years of follow-up.”
Bonavina et al.31 (2008)Case series (n=41)Magnetic Sphincter Augmentation (MSA) deviceThe GERD HRQoL score decreased from 26 to 1 [average follow-up 209 days (range 12-434)]. 89% of patients discontinued use of antireflux medications, and normal 24-hour pH was reported in 79% of patients. All patients were able to belch, and 49% experienced mild dysphagia. No device migrations or erosions occurred.“Laparoscopic implant of the MSA device is safe and well tolerated. It requires minimal surgical dissection and a short learning curve compared to the conventional Nissen fundoplication.”
FDA Summary of Safety and Effectiveness15Multi-institutional, non-randomized, prospective case series (n=100)LINX reflux management systemPrimary endpoint:
Either normalization of pH, or a reduction of at least 50% in total time that pH <4, relative to baseline. Sixty-four (64) of the 100 implanted subjects achieved success. The lower limit of the 97.5% confidence interval fell below success threshold and, therefore, primary endpoint not met.First secondary endpoint:
Reduction in GERD symptoms defined by the GERD-HRQL questionnaire. Success was defined as a reduction of 50% in the total GERD-HRQL score at 12 months post implantation as compared to baseline score off PPI therapy. The majority of subjects had at least 50% improvement in their scores.Second secondary endpoint:
Reduction in PPI use. Success was defined as a reduction in PPI daily use by >_ 50% at 12 months post implantation as compared to a subject’s baseline PPI use. At 24 months, 96% of subjects met the endpoint.
“Although the primary objective of the study was not met, FDA considered the improvement in esophageal pH that was seen in 64% of subjects in addition to the improvement in GERD symptoms and reduction in PPI medication use demonstrated a reasonable assurance as to the effectiveness of the L1NX Reflux Management System.”
Ganz et al.32 (2013)Multi-institutional, non-randomized, prospective case series (n=100)LINX reflux management systemThe primary outcome was achieved in 64% of patients (95% confidence interval[CI], 54 to 73). For the secondary outcomes, a reduction of 50% or more in the use of proton-pump inhibitors occurred in 93% of patients, and there was improvement of 50% or more in quality-of-life scores in 92%, as compared with scores for patients assessed at baseline while they were not taking proton-pump inhibitors. The most frequent adverse event was dysphagia (in 68% of patients postoperatively, in 11% at 1 year, and in 4% at 3 years). Serious adverse events occurred in six patients, and in six patients the device was removed.In this single-group evaluation of 100 patients before and after sphincter augmentation with a magnetic device, exposure to esophageal acid decreased, reflux symptoms improved, and use of proton-pump inhibitors decreased. Follow-up studies are needed to assess long-term safety.

4. Safety and Efficacy Data

The literature search found reports on 2 FDA-approved IDE clinical studies. The initial feasibility study was a prospective, multi-center, non-randomized case series that enrolled 44 patients between February 2007 and October 2008 at 4 sites in the US and Europe (11 LINX procedures performed in the US and and 33 in Europe). Three separate publications report results at 3-months31, 1 to 2 years30, and 4 years29. The pivotal study was a prospective, non-randomized, multi-center clinical trial enrolling 100 patients (96 US and 4 European) at 14 sites (13 US and 1 European). Data from 2-year follow-up were presented in FDA documents as part of the pre-market approval process15. Three year follow-up on the pivotal trial was recently published as well32.

Bonavina et al. (2008) conducted a multicenter feasibility trial to evaluate safety and efficacy of the “magnetic sphincter augmentation device.” Patients with typical heartburn (at least partially responding to proton-pump inhibitors), abnormal esophageal acid exposure, and normal esophageal peristalsis were enrolled. Patients with hiatal hernia >3 cm were excluded from the study. Over a 1-year period, 38 out of 41 enrolled patients underwent this procedure in 3 hospitals. No operative complications were recorded. A free diet was allowed since post-operative day one, and 97%of patients were discharged within 48 h. The mean follow-up was 209 days (range 12–434 days). The GERD-HRQL score decreased from 26.0 to 1.0 (p < 0.005). At 3 months postoperatively, 89% of patients were off anti-reflux medications, and 79% of patients had a normal 24-h pH test. All patients preserved the ability to belch. Mild dysphagia occurred in 45% of patients. No migrations or erosions of the device occurred. The authors concluded, “Laparoscopic implantation of the magnetic sphincter augmentation device is safe and well tolerated. It requires minimal surgical dissection and a short learning curve compared to the conventional Nissen fundoplication.”

Bonavina et al. (2010) conducted a 1 and 2-year evaluation of the above feasibility trial. At baseline, all 44 patients had abnormal esophageal acid exposure on 24-hour pH monitoring and improved, but persistent, typical GERD symptoms while on acid suppression therapy with PPIs. Patients were evaluated after surgery by GERD Health-Related Quality of Life symptom score, PPI usage, endoscopy, esophageal manometry, and 24-hour esophageal pH monitoring. The total mean GERD Health-Related Quality of Life symptom scores improved from a mean baseline value of 25.7 to 3.8 and 2.4 at 1 and 2-year follow-up, representing an 85% and 90% reduction, respectively (P < 0.0001). Complete cessation of PPI use was reported by 90% of patients at 1 year and by 86% of patients at 2 years. Early dysphagia occurred in 43% of the patients and self-resolved by 90 days. One device was laparoscopically explanted for persistent dysphagia without disruption of the anatomy or function of the cardia. There were no device migrations, erosions, or induced mucosal injuries. At 1 and 2 years, 77% and 90% of patients had a normal esophageal acid exposure. The mean percentage time pH was less than 4 decreased from a baseline of 11.9% to 3.1% (P < 0.0001) at 1 year and to 2.4% (P < 0.0001) at 2 years. Patient satisfaction was 87% at 1 year and 86% at 2 years. The authors conclude, “The new laparoscopically implanted sphincter augmentation device eliminates GERD symptoms without creating undue side effects and is effective at 1 and 2 years of follow-up.”

As a follow-up to the Bonavina et al. (2010) study, Lipham et al. (2012) evaluated these 44 patients at 3 and 4 years. Each patient’s baseline GERD status served as the control for evaluations post implant. For esophageal acid exposure, the mean total % time pH < 4 was reduced from 11.9 % at baseline to 3.8 % at 3 years, with 80 % of patients achieving pH normalization. At ≥4 years, 100 % of the patients had improved quality-of-life measures for GERD, and 80 % had complete cessation of the use of proton pump inhibitors (PPIs). There have been no reports of long-term device-related complications such as migration or erosion. The authors concluded that, “Sphincter augmentation with the LINX Reflux Management System provided long-term clinical benefits with no safety issues as demonstrated by reduced esophageal acid exposure, improved GERD-related quality of life, and cessation of dependence on PPIs, with minimal side effects and no safety issues. Patients with inadequate symptom control with acid suppression therapy may benefit from treatment with sphincter augmentation.”

In the FDA Summary of Safety and Effectiveness Data (SSED) document, with regards to safety, the FDA concludes: “The safety of the LINX Reflux Management System in the treatment of subjects with GERD was based on adverse event data from 100 subjects followed for up to 24 months. The 12-month data demonstrated 162 total adverse events reported in 76% of the subjects. Most adverse events resolved without sequelae. Dysphagia was the most common adverse event with 76 events being reported in 68% of the subjects, with 11% of the subjects reporting ongoing dysphagia. Eighteen (18) subjects underwent esophageal dilatation and 10 continued to have dysphagia at 24 months. Furthermore, there were several subjects who experienced symptoms of odynophagia/dysphagia that started after 180 days (182-605) and several subjects who had odynophagia and/or dysphagia that took over 180 days to resolve (maximum time noted 447 days). Overall, the incidence of dysphagia was found to be comparable to the incidence of dysphagia that is reported in patients undergoing anti-reflux surgery, such as Nissen fundoplication. Overall, the safety data from the pivotal trial supports a reasonable assurance that the LINX device is safe.”

With regards to effectiveness, based on the pivotal trial data the FDA concludes: “While the success criterion for the pre-specified primary objective of the study (pH normalization or a ≥ 50% reduction in distal esophageal acid exposure) was not met, there was improvement in esophageal pH. Sixty four of 100 subjects met the primary endpoint; there were 56 subjects who had normalization of pH and another 8 subjects who had a least a 50% reduction in total time that the pH < 4, however the lower limit of the 97.5% confidence interval was only 53.8% instead of the pre-specified 60%. Even more subjects had success in meeting the secondary objectives of improvement in GERD symptoms and reduction in PPI usage. The success rate for reduction in GERD symptoms was 92% at 12 months and 84% at 24 months. Similarly, reduction of at least 50% in PPI use was seen in 93% of subjects at 12 months and 86% at 24 months. The majority of these subjects, 88 at 12 months and 83 at 24 months, eliminated their use of PPIs. Although the primary objective of the study was not met, FDA considered the improvement in esophageal pH that was seen in 64% of subjects in addition to the improvement in GERD symptoms and reduction in PPI medication use demonstrated a reasonable assurance as to the effectiveness of the LINX Reflux Management System.”

Ganz et al. (2013) published 3-year follow-up data on the 100 patients enrolled in the pivotal trial. With regards to safety, “serious adverse events occurred in six patients and required removal of the device in four of the six. In three of the patients, the device was removed at 21, 31, and 93 days after implantation because of persistent dysphagia, with resolution in all three patients after removal, and in one patient, the device was removed at 357 days owing to intermittent vomiting of unknown cause starting 3 months after implantation, without relief after removal.” The most frequent adverse event was dysphagia, which occurred in 68% of patients postoperatively. Ongoing dysphagia was noted in 11% of patients at 1 year, in 5% at 2 years, and in 4% at 3 years. Esophageal dilation for dysphagia was allowed at the discretion of the investigator. A total of 19 patients underwent dilation, with 16 reporting improvement after the procedure. Chest radiography and endoscopy performed at 1 year and at 2 years after implantation showed no evidence of device migration or erosion. At 3 years, 2 patients reported an inability to belch or vomit. With regards to safety, the authors concluded, “Studies with larger samples and longer term follow-up are needed to confirm these early results and assess longer-term safety.”

With regards to effectiveness, Ganz and colleagues (2013) determined that normalization of or at least a 50% reduction in esophageal acid exposure was achieved in 64% of patients (64 of 100; 95% confidence interval [CI], 54 to 73). The secondary efficacy end point, a 50% reduction in the quality of life score, as compared with the score without proton-pump inhibitors at baseline, was achieved in 92% of patients (92 of 100; 95% CI, 85 to 97). A reduction of 50% or more in the average daily dose of proton-pump inhibitors occurred in 93% of patients (93 of 100 patients; 95% CI, 86 to 97). With regards to effectiveness, the authors concluded that the magnetic device decreased exposure to esophageal acid, improved reflux symptoms, and allowed cessation of proton-pump inhibitors in the majority of patients.

A search of the ClinicalTrials.gov website identified two ongoing trials sponsored by Torax Medical. A five-year follow-up study is still ongoing to provide long-term data, which will not be available until October 2013. The primary outcome measure is to evaluate the incidence of all adverse events at various time points [Time Frame: 5 years].

http://www.clinicaltrials.gov/ct2/show/NCT01058070?term=NCT01058070&rank=1 (accessed December 2012)

The second trial ongoing registered clinical trial has an estimated completion date of to October 2014. Primary outcome measures for this second trial include the rate of occurrence for serious device and procedure related adverse events and reduction in esophageal acid exposure time defined by esophageal pH testing [Time Frame for adverse events: 12 months and annually to 60 months. Time Frame for pH: 12 months].

http://www.clinicaltrials.gov/ct2/show/NCT00776997?term=NCT00776997&rank=1 (accessed December 2012)

5. Limitations of currently published data

Feasibility trial

  • Lack of randomization and blinding
    • It would not be feasible to blind patients or physicians to a laparoscopic procedure
    • PPI randomization would be a potential impediment to adequate patient enrollment due to limited PPI efficacy in the target population
  • Small case series
  • Limited follow-up
  • Only data from trial patients is included. Outcomes in actual clinical practice outside of a clinical trial may differ from those reported.

Pivotal trial

  • Lack of randomization and blinding
  • Lack of direct comparison to fundoplication
  • Predefined therapeutic end point not met
  • Small case series
  • Limited follow-up
  • Only data from trial patients is included. Outcomes in actual clinical practice outside of a clinical trial may differ from those reported.

6. Expert Panel Recommendation

This expert panel convened by the SAGES Technology and Value Assessment Committee finds that:

With regards to safety:

  • Safety analyses suggest the LINX procedure was associated with few serious adverse events and no reported mortality.
  • The most common complication was acute dysphagia.
  • Patients maintain their ability to belch following the LINX procedure.
  • Long-term (4 to 5-year) follow-up of patients in the feasibility trial have shown no migration or erosion of the device into the esophagus.
  • Overall, the safety data from the pivotal trial supports a reasonable assurance that the LINX device is safe.

With regards to efficacy, the panel concludes:

  • Currently available data demonstrates a reasonable assurance as to the efficacy of the LINX Reflux Management System.

Conclusions:

  • Implantation of the LINX device requires minimal dissection and relatively few technical steps when compared to Nissen fundoplication. This may enable the LINX surgical technique to be standardized in a manner not possible for fundoplication.
  • The mechanism of action of the LINX device results in a low incidence of difficulty belching.
  • The incidence of initial dysphagia following LINX implantation is high. Difficulty swallowing was more commonly reported at 12 and 24 months following LINX implantation than at baseline. Patients should be advised about the possibility that it may be more difficult to swallow following surgery, and that this symptom may persist.
  • The LINX device may provide an option currently lacking in clinical practice for patients with medically refractory GERD who have not yet progressed to end-stage reflux disease with associated complications.
  • Direct comparative studies between the LINX procedure and Nissen fundoplication will be needed
  • On the basis of the available evidence, the LINX device should be an option available to patients and providers for the management of medically refractory GERD.

References

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29 Lipham, JC, Demeester, TR, Ganz, RA, Bonavina, K, Saino, G, Dunn, DH, Fockens, P, and Bemelman, W (2012) The LINX reflux management system: confirmed safety and efficacy now at 4 years. Surg Endosc; 26: 2944-9
30 Bonavina, L, DeMeester, T, Fockens, P, Dunn, D, Saino, G, Bona, D, Lipham, J, Bemelman, W, and Ganz, RA (2010) Laparoscopic sphincter augmentation device eliminates reflux symptoms and normalizes esophageal acid exposure: one- and 2-year results of a feasibility trial. Ann Surg; 252(5):857-862
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This document was prepared and revised by SAGES Technology and Value Assessment Committee

  • Dmitry Oleynikov, Chair
  • Matthew Hutter, Co-Chair
  • Bolanle Asiyanbola
  • William Bertucci
  • Daniel Birch
  • Angel Caban
  • Diego Camacho
  • Caroline Cao
  • Eugene Cho
  • Hui Sen Chong
  • Ronald Clements
  • Giovanni Dapri
  • Brian Dunkin
  • Robert Fanelli
  • Antonello Forgione
  • Prakash Gatta
  • Eric Haas
  • Randy Haluck
  • Jarrod Kaufman
  • Herbert Lerner
  • Thom Lobe
  • Preeti Malladi
  • Corrigan McBride
  • Oznan Meireles
  • Yoav Mintz
  • Brant Oelschlager
  • Raymond Onders
  • Lucian Panait
  • Richard Parent
  • Kyle Perry
  • Richard Pierce
  • Todd Ponsky
  • David Renton
  • Sharona Ross
  • James "Butch" Rosser, Jr.
  • Bryan Sandler
  • Richard Satava
  • Paresh Shah
  • Christiana Shaw
  • Danny Sherwinter
  • C. Daniel Smith
  • Kathrin Troppmann
  • Victor Tsirline
  • Shawn Tsuda
  • Basil Yurcisin

This statement was reviewed and approved by the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) on Apr 2013.

SAGES publication #TAVAC01

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Guidelines for clinical practice are intended to indicate preferable approaches to medical problems as established by experts in the field. These recommendations will be based on existing data or a consensus of expert opinion when little or no data are available. Guidelines are applicable to all physicians who address the clinical problem(s) without regard to specialty training or interests, and are intended to indicate the preferable, but not necessarily the only acceptable approaches due to the complexity of the healthcare environment. Guidelines are intended to be flexible. Given the wide range of specifics in any health care problem, the surgeon must always choose the course best suited to the individual patient and the variables in existence at the moment of decision.

Guidelines are developed under the auspices of the Society of American Gastrointestinal and Endoscopic Surgeons and its various committees, and approved by the Board of Governors. Each clinical practice guideline has been systematically researched, reviewed and revised by the guidelines committee, and reviewed by an appropriate multidisciplinary team. The recommendations are therefore considered valid at the time of its production based on the data available. Each guideline is scheduled for periodic review to allow incorporation of pertinent new developments in medical research knowledge, and practice.