Background

Gastroesophageal Reflux Disease

GERD is defined as the reflux of stomach acid into the esophagus that causes symptoms and/or mucosal injury. GERD is a common medical disorder, with estimates of 10% to 20% prevalence in developed countries.

Regulatory Status

In 2012, the LINX™ Reflux Management System (Torax Medical) was approved by the U.S. Food and Drug Administration through the premarket approval process for patients diagnosed with GERD, as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximal therapy for the treatment of reflux. The Food and Drug Administration initially required a 5-year follow-up of 100 patients from the investigational device exemption pivotal study to evaluate the safety and efficacy of the device, which was completed in March 2016. Food and Drug Administration product code: LEI.

Related Policies

• Transesophageal Endoscopic Therapies for Gastroesophageal Reflux Disease (Policy #032 in the Treatment Section)

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, two domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Clinical Context and Therapy Purpose

The purpose of magnetic sphincter augmentation (MSA) in patients who have GERD is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this policy is: Does the use of MSA improve the net health outcome in individuals with GERD who have not responded to optimal medical management?

The following PICOs were used to select literature to inform this policy.

Patients

The relevant population of interest are individuals with GERD who have not responded to optimal medical management

The severity of GERD varies widely. Many patients have mild, intermittent symptoms that do not require treatment or only require episodic use of medications. Other patients have chronic, severe GERD that can lead to complications such as Barrett esophagus and esophageal cancer.

The Los Angeles (LA) classification system is used to describe the endoscopic appearance of reflux esophagitis and grade its severity. Esophagitis is confirmed by endoscopy according to a 5 grading severity scale.

• Not present: No breaks (erosions) in the esophageal mucosa (edema, erythema, or friability may be present).
• Grade A: One or more mucosal breaks confined to the mucosal folds, each not more than 5 mm in maximum length.
• Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of two mucosal folds.
• Grade C: Mucosal breaks that are continuous between the tops of tow or more mucosal folds, but which involve less that 75% of the esophageal circumference.
• Grade D: Mucosal breaks which involve at least 75% of the esophageal circumference.

The therapy being considered is MSA. The LINX Reflux Management System is composed of a small flexible band of 10 to 18 interlinked titanium beads with magnetic cores. Using standard laparoscopic techniques, the band is placed around the esophagus at the level of the gastroesophageal junction. The magnetic attraction between the beads is intended to augment the lower esophageal sphincter to prevent gastric reflux into the esophagus, without compressing the esophageal wall. It is proposed that swallowing food or liquids creates sufficient pressure to overcome the magnetic bond between the beads, allowing the beads to separate and temporarily increase the size of the ring. MSA is a 30-minute surgical procedure performed under general anesthesia that includes testing of the esophageal sphincter. MSA is a minimally invasive procedure conducted in an inpatient surgical center and requires an overnight stay. The device manufacturer claims patients resume a normal diet within 24 hours postsurgery. The device can be removed by a laparoscopic procedure if severe adverse events occur or if magnetic resonance imaging is needed for another condition.

Comparators

The following therapies and practices are currently being used to treat GERD that has not responded to optimal medical therapy: lifestyle modifications, continued medical therapy and interventions to strengthen the lower esophageal sphincter.

Lifestyle modifications may include weight loss, elevation of the head of the bed, avoidance of meals close to bedtime, and elimination of dietary triggers. For patients with severe disease, chronic treatment with acid suppressive therapies is an option. For some patients, medications are inadequate to control symptoms; other patients prefer to avoid the use of indefinite, possibly lifelong medications. Surgical treatments are available for these patients, primarily a Nissen fundoplication performed either laparoscopically or by open surgery. A number of less invasive procedures are also being evaluated as an intermediate option between medical therapy and surgery (see 'Transesophageal Endoscopic Therapies for Gastroesophageal Reflux Disease' (Policy #032 in the Treatment Section)).

In patients who continue to have symptoms despite once daily PPIs (e.g., omeprazole 20 mg), guideline based recommendations include increasing and/or splitting the PPI dose), and switching to a different PPI to optimize pharmacologic treatment.

Outcomes

The general outcomes of interest are a reduction in symptoms such as heartburn and regurgitation, reduction in acid suppression medication use, QOL, treatment-related adverse events, device failure, and progression to Barrett esophagus and esophageal cancer.

A variety of scales have been developed to measure patient and investigator-reported GERD symptoms. Frequently used measures of QOL include the GERD-HRQ, a scale with 11 items focusing on heartburn symptoms, dysphagia, medication effects, and the patient's present health condition. Each item is scored from 0 to 5, with a higher score indicating a better QOL, and GERD-QO, a scale with 16 items clustered into the following four subscales: daily activity, treatment effect, diet, and psychological well-being. The total score of this questionnaire is the average of the four subscale scores. The final score can range from 0 to 100, with a higher score indicating a better QOL.

Study Selection Criteria

To assess efficacy outcomes, we sought comparative controlled prospective trials, with a preference for RCTs and systematic reviews of these studies.

A placebo control is optimal due to the subjective nature of the patient-reported outcome measures, which are prone to bias if the patient is not blinded to treatment assignment. Random assignment is important because of the multiple potential confounders of GERD outcomes, such as diet, smoking, and obesity. GERD has a variable natural history, with exacerbations and remissions, and, as a result, a control group is required to differentiate improvements in symptoms from the natural history of the disorder. In the absence of such trials, we sought comparative observational studies, with a preference for prospective studies. To assess long-term outcomes and adverse effects, we also sought single-arm studies that captured longer periods of follow-up and/or larger populations

Systematic Reviews

Two recent systematic reviews compared MSA to laparoscopic Nissen fundoplication (LNF) in patients with GERD (Table 1).^1,2, Both conducted meta-analyses of comparative observational studies and concluded that MSA and LNF had similar effects on symptoms and QOL (Table 2). The body of evidence was limited, however, by the retrospective design of most studies, and the reviewers concluded that RCT evidence was needed.

Table 1. Characteristics of Systematic Reviews of MSA Compared to LNF

Study	Dates	Trials	Participants	N (Range)	Design	Duration
Guidozzi et al (2019)1,	1987-2013	6 comparative observational 13 single-arm cohort	Patients with GERD	Comparative observational studies: 1099 (24-415)	Comparative observational	Range 6-44 months
Aiolfi et al (2018)2,	2000-2015	6	Patients with GERD	2561 (23-335)	Comparative observational (1 prospective, 5 retrospective cohort)	Up to 1 year

MSA: magnetic sphincter augmentation; LNF laparoscopic Nissen fundoplication; GERD: gastroesophageal reflux disease.

Table 2. Results of Systematic Reviews of MSA Compared to LNF

Study	Need for PPI	GERD-HRQL	Dysphagia	Need for Reoperation
Guidozzi et al (2019)1,
Total N	5 studies (861)	3 studies (760)	4 studies (795)	4 studies (754)
Pooled effect (95% CI)	OR 1.08 (0.40 to 2.95); P=0.877	WMD 0.34 (-0.70 to 1.37); P=0.525	OR 0.94 (0.57 to 1.55); P=0.822	OR 1.23 (0.26 to 5.8); P=0.797
I2 (p)	72% (0.007)	70.6% (0.033)	20.4% (0.288)	48.5% (0.12)
Aiolfi et al (2018)2,	PPI suspension		Dysphagia requiring endoscopic dilatation
Total N	6 studies (1098)	6 studies (1083)	5 stuides (535)	3 studies (1187)
Pooled effect (95% CI)	OR 0.81 (0.42 to 1.58); P=0.548	MD -0.48 (-1.05 to 0.09); P=0.101	OR 1.56 (0.61 to 3.95); P=0.119	OR 0.54 (0.22 to 1.34); P=0.183
I2 (p)	63.9% (0.016)	0% (0.82)	35% (0.19)	0% (0.814)

MSA: magnetic sphincter augmentation; LNF laparoscopic Nissen fundoplication; PPI: proton pump inhibitor; GERD-HRQL: gastroesophageal reflux disease health-related quality of lIfe scale; N: sample size;CI: confidence interval; OR: odds ratio; WMD: weighted mean difference; MD: mean difference.

Randomized Controlled Trial

There are no RCTs of MSA compared to LNF. There is one open-label RCT comparing MSA to twice-daily omeprazole 20 mg in 152 patients with regurgitation symptoms despite once daily omeprazole 20 mg (Table 3). The primary endpoint was the percent of patients who achieved elimination of moderate-to-severe regurgitation at 6 months, as reported by patients on the Foregut Symptom Questionnaire (FSQ). The FSQ evaluates the severity of regurgitation symptoms: none, mild (after straining or large meals), moderate (predictable with position change, lying down, straining), and severe (constant). Esophageal reflux parameters (number of reflux episodes and percentage of time with pH <4 and PPI use were secondary endpoints. At six months, significantly more patients who received MSA reported improvements in symptoms and QOL than those in the control group (Table 4). Ninety-one percent of those who received the surgery were able to maintain discontinuation of proton pump inhibitor (PPIs) at six months. Patients who received MSA testing had less reflux, as measured by impedance-pH testing. Follow-up in randomized arms continued for 6 months after which patients in the medical therapy arm could elect to receive MSA; results for patients who crossed over to MSA were similar to those who were randomized to MSA.^3,

Relevance and study design and conduct limitations of the RCT conducted by Bell et al (2019) are shown in Tables 5 and 6. A major limitation of the trial was that the patients had not received optimal medical treatment prior to enrollment. Additional limitations included the use of subjective outcome measures along with an open-label design, although this is less of a concern because results were supported by better results for MSA on some objective measures (see Table 4). For patients who have not responded to optimal medical treatment, an appropriate comparator would be Nissen fundoplication.

Table 3. Summary of Key RCT Characteristics

Study; Trial	Countries	Sites	Dates	Participants	Interventions
Bell et al (2019)4, NCT02505945	U.S.	21	2015-2017	152 patients with moderate to severe regurgitation symptoms while on once-daily PPIs and actively seeking alternative, surgical treatment for regurgitation symptoms	Laparoscopic MSA (N=50)	Omeprazole 20 mg twice daily (N=102)

RCT: randomized controlled trial; MSA magnetic sphincter augmentation; PPI: proton pump inhibitor.

Table 4. Summary of Key RCT Results

Study	Symptoms	Quality of Life		PPI Discontinuation	Impedance-pH Testing				Withdrawals
Bell et al (2019)4,3, NCT02505945
	134	134	134		123	123	123	123	148
	Resolution of moderate - to - severe regurgitation (FSQ) at 6 months	Mean decrease in GERD-HRQL score at 6 months	>50% decrease in GERD-HRQL score at 6 months		Number of Reflux Events per 24 hours	Percentage of time with pH<4 per 24 hours	Normal number of reflux episodes	Normal acid exposure
MSA	42/47 (89%)	18	38/47 (81%)	43/47 (91%)	22.5 (IQR,13.0-40.5)	2%	40/44 (91%)	39/44 (89%)	0/47 (0%)
Omeprazole	101/101 (10%)	1	7/87 (8%)	NR	49.0 (IQR 31.0-76.78	5%	46/79 (58%)	59/79 (75%)	13/101 (12.9%)
P-value for difference	<0.001	<0.002	<0.001		<0.001	0.065	<0.001	0.065	NR

RCT: randomized controlled trial; N: sample size; FSQ: Foregut Symptom Questionnaire; GERD-HRQL: gastroesophageal reflux disease health-related quality of life scale; NR: not reported; PPI: proton pump inhibitor. IQR: interquartile range

Table 5. Relevance Limitations

Study	Populationa	Interventionb	Comparatorc	Outcomesd	Follow-Upe
Bell et al (2019)4, NCT02505945	4. Patients did not receive optimal medical therapy prior to study enrollment		2. Did not compare the intervention to Nissen fundoplication

BID: twice daily; GERD: gastroesophageal reflux disease.

The study limitations stated in this table are those notable in the current review; this is not a comprehensive limitations assessment.

^a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.

^b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest.

^c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.

^d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.

^e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Study	Allocationa	Blindingb	Selective Reportingc	Data Completenessd	Powere	Statisticalf
Bell et al (2019)4, NCT02505945	1. Differences between groups at baseline	1. Not blinded		1. Differential loss to follow-up (12.9% in PPI group vs 0 in MSA group)		4. CIs for treatment effects not calculated

The study limitations stated in this table are those notable in the current review; this is not a comprehensive limitations assessment.

^a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.

^b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.

^c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.

^d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).

^e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.

^f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Data submitted to the FDA for the LINX Reflux Management System included 2 single-arm FDA-regulated investigational device exemption (IDE) trials (total n=144 subjects) and follow-up data between 2 and 4 years.^5, The feasibility IDE trial enrolled 44 subjects at 4 clinical sites (2 U.S., 2 Europe) and had published data out to 4 years.^8,9 The pivotal IDE trial included 100 subjects from 14 clinical sites (13 U.S., 1 Europe) who had documented symptoms of GERD for more than 6 months (regurgitation or heartburn that responds to acid neutralization or suppression), required daily PPI or other antireflux drug therapy, had symptomatic improvement on PPI therapy, and had a total distal ambulatory esophageal pH less than 4 for 4.5% or more of the time when off GERD medications. The primary safety endpoint measured the rate of related device and procedure serious adverse events. Efficacy endpoints were assessed off PPI therapy and measured esophageal acid exposure, total GERD-HRQL scores, and PPI usage. Subjects served as their own controls.

Five-year results for the 100 patients in the pivotal IDE trial were published by Ganz et al (2016).^6, Eighty-five patients had a follow-up at five years. Of those 85, 83% achieved had a 50% reduction in GERD-HRQL scores (95% CI, 73% to 91%), and 89.4% had a reduction of 50% or more in an average daily dose of PPI (95% CI, 81% to 95%). No new major safety concerns emerged. The device was removed in seven patients.

Additional single-arm observational studies have reported on outcomes after MSA in sample sizes ranging from 121 to 192 patients,^7,8,9,10, some of which focused on specific subpopulations of individuals with GERD, such as those with large hiatal hernias (e.g., Rona et al [2017]).^10,

Summary of Evidence

For individuals who have GERD who receive magnetic sphincter augmentation (MSA), the evidence includes one randomized controlled trial comparing MSA to proton pump inhibitor therapy, comparative observational studies of MSA vs laparoscopic Nissen fundoplication, single-arm cohort studies, and systematic reviews of observational studies.. The relevant outcomes are symptoms, change in disease status, medication use, and treatment-related morbidity. A randomized controlled trial comparing MSA to omeprazole 20 mg twice daily found significantly more patients who received MSA reported improvements in symptoms and quality of life at six months. A major limitation of the trial was that the patients had not received optimal medical treatment prior to enrollment. In the two single-arm, uncontrolled manufacturer-sponsored studies submitted to the U.S. Food and Drug Administration with materials for device approval, subjects showed improvements in GERD-health-related quality of life scores and reduced proton pump inhibitor use. Similarly, observational comparative studies, most often comparing MSA with laparoscopic Nissen fundoplication, generally have shown that GERD-health-related quality of life scores do not differ significantly between fundoplication and MSA, and patients can reduce proton pump inhibitor use after MSA. However, the comparative studies are retrospective and nonrandomized, may be affected by selection bias, and the subjective outcome measures used in these studies (e.g., the GERD-health-related quality of life scores) may be biased.. Randomized comparisons of MSA with laparoscopic Nissen fundoplication are needed to evaluate the relative risk-benefit of these two procedures. The evidence is insufficient to determine the effects of the technology on health outcomes.

SUPPLEMENTAL INFORMATION

Practice Guidelines and Position Statements

Society of American Gastrointestinal and Endoscopic Surgeons

The Society of American Gastrointestinal and Endoscopic Surgeons (2013) published guidelines on the safety and effectiveness of the LINX Reflux Management System.^11, The Society indicated that safety analyses of the LINX system suggested the procedure is associated with few serious adverse events and no reported mortality, and that currently available data demonstrated a reasonable assurance as to the efficacy of the system. The guidelines concluded that direct comparative studies between the LINX procedure and Nissen fundoplication would be needed, although, based on the available evidence, the LINX device should be an option available to patients and providers for the management of medically refractory gastroesophageal reflux disease.

American Society for Gastrointestinal Endoscopy

A report from the American Society for Gastrointestinal Endoscopy (2013) concluded that long-term data on the safety and efficacy of the LINX device were needed.^12, The document indicated that the LINX band is currently being deployed laparoscopically; however, a natural orifice transluminal endoscopic surgery approach could be explored.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Ongoing and Unpublished Clinical Trials

Some currently ongoing and unpublished trials that might influence this policy are listed in Table7.

Table 7. Summary of Key Trials

NCT No.	Trial Name	Planned Enrollment	Completion Date
Ongoing
NCT02429830a	RELIEF Study: A Prospective, Multicenter Study of REflux Management With the LINX® System for Gastroesophageal REFlux Disease After Laparoscopic Sleeve Gastrectomy	30	Oct 2019
NCT02923362	Registry of Outcomes From AntiReflux Surgery (ROARS)	2500	May 2025
NCT01940185a	A Post-Approval Study of the Lynx® Reflux Management System	200	Oct 2025

NCT: national clinical trial.

^a Denotes industry-sponsored or cosponsored trial.]
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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Magnetic Esophageal Sphincter Augmentation to Treat Gastroesophageal Reflux Disease
Magnetic Esophageal Ring to Treat Gastroesophageal Reflux Disease (GERD)
LINX Reflux Management System
Laparoscopic Implantation of Magnetic Esophageal Ring
GERD, Implantable Magnetic Esophageal Ring for
Gastroesophageal Reflux Disease, Implantable Magnetic Esophageal Ring for
Implantable Magnetic Esophageal Ring for GERD

References:
1. Guidozzi N, Wiggins T, Ahmed AR et al. Laparoscopic magnetic sphincter augmentation versus fundoplication for gastroesophageal reflux disease: systematic review and pooled analysis. Dis. Esophagus, 2019 May 10. PMID 31069388.

2. Aiolfi A, Asti E, Bernardi D et al. Early results of magnetic sphincter augmentation versus fundoplication for gastroesophageal reflux disease: Systematic review and meta-analysis. Int J Surg, 2018 Feb 23;52:82-88. PMID 29471155.

3. Bell R, Lipham J, Louie BE et al. Magnetic Sphincter Augmentation Superior to Proton Pump Inhibitors for Regurgitation in a 1-Year Randomized Trial. Clin. Gastroenterol. Hepatol., 2019 Sep 14. PMID 31518717.

4. 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. Gastrointest. Endosc., 2018 Jul 22;89(1). PMID 30031018.

5. U.S. Food and Drug Administration, Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee. LINXTM Reflux Management System. 2012; https://wayback.archive- it.org/7993/20170113140208/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM286236.pdf. Accessed October 9, 2019.

6. Ganz RA, Edmundowicz SA, Taiganides PA, et al. Long-term outcomes of patients receiving a magnetic sphincter augmentation device for gastroesophageal reflux. Clin Gastroenterol Hepatol. May 2016;14(5):671- 677. PMID 26044316.

7. Smith CD, DeVault KR, Buchanan M. Introduction of mechanical sphincter augmentation for gastroesophageal reflux disease into practice: early clinical outcomes and keys to successful adoption. J Am Coll Surg. Apr 2014;218(4):776-781. PMID 24529809.

8. Reynolds JL, 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. Am Surg. Oct 2014;80(10):1034-1038. PMID 25264655.

9. Warren HF, Louie BE, Farivar AS, et al. Manometric changes to the lower esophageal sphincter after magnetic sphincter augmentation in patients with chronic gastroesophageal reflux disease. Ann Surg. Jul 2017;266(1):99- 104. PMID 27464617.

10. Rona KA, Reynolds J, Schwameis K, et al. Efficacy of magnetic sphincter augmentation in patients with large hiatal hernias. Surg Endosc. May 2017;31(5):2096-2102. PMID 27553803.

11. SAGES: Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). TAVAC Category: Safety and Effectiveness. LINX Reflux Management System. 2017; https://www.sages.org/publications/tavac/tavac-safety-and-effectiveness-analysis-linx-reflux-management-system/. Accessed October 9, 2019.

12. ASGE Technology Committee. Magnets in the GI tract. Gastrointest Endosc. Oct 2013;78(4):561-567. PMID 24054738.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

43284
43285