Archived Policies - Surgery
Magnetic Esophageal Ring to Treat Gastroesophageal Reflux Disease (GERD)
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A laparoscopically implantable magnetic esophageal ring (LINX™ Reflux Management System) is considered medically necessary as a treatment alternative to surgical fundoplication, when the patient has chronic gastroesophageal reflux disease (GERD) symptoms (reflux symptoms that occur two or more times per week) AND are refractory to maximum medical therapy.
The safety and effectiveness of a laparoscopically implantable magnetic esophageal ring (LINX™ Reflux Management System) has not been established and/or is contraindicated and therefore considered experimental, investigational and/or unproven for patients with any other indication including but not limited to the following conditions:
Removal of an esophageal sphincter augmentation device may be considered medically necessary when all the following criteria are met:
Gastroesophageal Reflux Disease
Gastroesophageal reflux disease (GERD) is defined as 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. 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’s esophagus and esophageal cancer.
For patients with severe disease, chronic treatment with acid blockers is an option. For some patients, medications are not adequate 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.
In 2012, the LINX™ Reflux Management System (Torax Medical, Shoreview, MN) was approved by the U.S. Food and Drug Administration (FDA) 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 maximum therapy for the treatment of reflux. The FDA initially required a 5-year follow-up of 100 patients from the investigational device exemption (IDE) pivotal study to evaluate safety and efficacy of the device, which was completed in March 2016. FDA product code: LEI.
This medical policy has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed through October 8, 2019.
Medical policies assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life (QOL), and ability to function-including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.
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 gastroesophageal reflux disease (GERD) is to provide a treatment option that is an alternative to or an improvement on existing therapies.
The question addressed in this medical 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.
The relevant population of interest are individuals with GERD who have not responded to optimal medical management (e g., proton pump inhibitors) but who do not want to risk the adverse effects of a surgical procedure like Nissen fundoplication. Adverse events of the LINX™ Reflux Management System may include dysphagia or odynophagia.
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.
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 post-surgery. The device can be removed by a laparoscopic procedure if severe adverse events occur or if magnetic resonance imaging is needed for another condition.
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 other less invasive procedures are also available as intermediate options between medical therapy and surgery; see MED201.016.
In patients who continue to have symptoms despite once daily proton pump inhibitors [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.
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 Gastroesophageal Reflux Disease-Health-Related Quality of Life (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 Gastroesophageal Reflux Disease-Quality of Life (GERD-QOL), a scale with 16 items clustered into the following four subscales: daily activity, treatment effect, diet, and psychological wellbeing. 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, comparative controlled prospective trials were sought, 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.
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. Although the body of evidence was limited, both concluded that MSA and LNF had similar effects on symptoms and QOL(Table 2).
Table 1. Characteristics of Systematic Reviews of MSA Compared to LNF
Guidozzi et al. (2019) (1)
6 comparative observational
13 single-arm cohort
Patients with GERD
Comparative observational studies: 1099 (24-415)
Range 6-44 months
Aiolfi et al. (2018) (2)
Patients with GERD
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 MSACompared to LNF
Need for PPI
Need for Reoperation
Guidozzi et al. (2019) (1)
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
Aiolfi et al. (2018) (2)
Dysphagia requiring endoscopic dilatation
6 studies (1098)
6 studies (1083)
5 studies (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
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.
Nonrandomized Comparative Studies
Retrospective comparative studies have been identified on magnetic sphincter augmentation (MSA) with the LINX device compared with laparoscopic Nissen fundoplication (LNF) or laparoscopic Toupet fundoplication (LTF).
The largest study identified is a multi-institutional retrospective cohort study by Warren, et al. (2016) who reported on 415 patients treated with either MSA (n=201) or LNF (n=214). (3) Eligible patients were retrospectively identified from 3 centers’ prospectively collected databases and met criteria if they had GERD at least partially responsive to proton pump inhibitor (PPI) treatment and positive pH testing. MSA-treated patients had lower DeMeester scores, and lower rates of biopsy-proven Barrett esophagus and hiatal hernia. Given the differences in baseline groups, the authors used propensity score matching to generate 114 matched pairs based on preoperative esophagitis, presence of Barret esophagus, hiatal hernia, and body mass index. Mean follow-up differed for matched pair MSA (11 months) and LNF groups (16 months; p<0.001). In quality of life analysis at follow-up, there was no significant difference in match- pair groups in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) scores (6 for MSA vs 5 for LNF, p=0.54). The proportion of patients using PPIs at follow-up was higher in the MSA group (24% vs 12%, p=0.02), but more patients in the MSA group had the ability for eructation (97% vs 66%, p<0.001).
Also in 2016, Asti et al. reported on an observational cohort study comparing MSA (n=135) and LTF (n=103), using patients identified from a prospectively collected database. (4) Eligible patients had GERD symptoms despite PPI for at least 6 months and normal esophageal motility. In a generalized estimating equation model for the GERD-HRQL, there was no significant difference at 1 year in GERD-HRQL scores between MSA and LTF groups (odds ratio for time-treatment interaction term, 1.04; 95% confidence interval [CI], 0.89 to 1.27; p=0.578). Similarly, there was no significant difference between the MSA and LTF groups at 1 year in PPI use (odds ratio for time-treatment interaction term, 1.18; 95% CI, 0.81 to 1.70; p=0.389).
Reynolds et al. (2015) reported on 1-year follow-up for 50 MSA and 50 LNF patients matched by disease severity. (5) To be included in the study, patients had 1) objective evidence of GERD, defined as an abnormal pH study, presence of biopsy-proven Barrett esophagus, or esophagitis grade B or greater; 2) PPI therapy for a minimum of 6 months; and 3) normal esophageal motility. Some patients had been included in previous reports. At 1 year after surgery, the 2 groups had similar GERD-HRQL scores (MSA=4.2 vs LNF=4.3; maximum, 50) and PPI use (MSA=17% vs LNF=8.5%). There was no difference in the number of patients reporting mild gas and bloating (MSA=27.6% vs LNF=27.6%), but more LNF patients reported severe gas and bloating (10.6% vs 0%, p=0.028). More LNF patients were unable to belch (MSA=8.5% vs LNF=25.5%, p=0.028) or vomit when needed (MSA=4.3% vs LNF=21.3%, p<0.002).
Louie et al. (2014) compared outcomes from 34 patients who had MSA with 32 patients who underwent LNF. (6) Similar improvements were found for both groups on the GERD-HRQL. The DeMeester score and pH normalized in both groups, but both were lower (p=0.001) in the fundoplication group. MSA allowed belching in 67% of patients compared with 0% in the fundoplication group.
Sheu et al. (2014) retrospectively compared outcomes from 12 MSA patients with a contemporaneous case-matched cohort of patients who underwent LNF. (7) Over half of the MSA patients were self-referred compared with none who underwent LNF. Both procedures were effective for reflux. Severe dysphagia requiring endoscopic dilation was more frequent after MSA (50% of cases), while there was a trend for a reduction in bloating, flatulence, and diarrhea in this study.
In 2015, Riegler et al. published 1-year results from an industry-sponsored multicenter registry (NCT01624506) that included a comparison with laparoscopic fundoplication. (8) The report included 202 MSA and 47 LNF or LTF patients from a planned enrollment of 734 patients. The choice of procedure was made by the surgeon at the time of laparoscopy, taking into account the presence of a large hiatal hernia and other factors. In addition to having a greater frequency of large hiatal hernias (>3 cm, 45.7% vs 1.6%), the fundoplication group was older and had a greater frequency of Barrett esophagus (19.1% vs 1.0%, p<0.001). Consistent with the greater severity of symptoms, patients who underwent fundoplication had greater regurgitation and fewer discontinued PPIs after treatment. Excessive gas and abdominal bloating (31.9% vs 10.0%) and inability to vomit (55.6% vs 8.7%) were significantly higher after fundoplication than after MSA. Improvements in GERD-HRQL scores were similar for the 2 groups.
Section Summary: Nonrandomized Comparative Studies
Observational comparative studies, most often comparing MSA with LNF, have generally shown that GERD-HRQL scores do not differ significantly between fundoplication and MSA, and patients can reduce PPI use after MSA.
Data submitted to the U.S. Food and Drug Administration (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. (9) The feasibility IDE trial enrolled 44 subjects at 4 clinical sites (2 U.S., 2 Europe) and had published data out to 4 years. (10, 11) 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.
Results of the pivotal trial were published in 2013. (12) In this trial, the primary efficacy end point of pH normalization or reduction of 50% or more in acid exposure time when off PPI was met by 64% of the subjects. Mean total acid exposure time was reduced from 11.6% at baseline to 5.1% at 12 months (56% reduction). The secondary efficacy end points met the study success criteria. Ninety-two percent of subjects had at least a 50% improvement in GERD-HRQL score (the mean GERD-HRQL total score decreased from 28.4 at baseline to 5.9 and 5.5 at 12 and 24 months, respectively), and 93% had reduced PPI use (79% and 83% of subjects were free from daily dependence at 12 and 24 months, respectively, vs 0% at baseline). Dysphagia was observed in 68% of patients postoperatively, in 11% at 1 year, and in 4% at 3 years. Nineteen patients underwent esophageal dilation for dysphagia. Six (6%) patients experienced a serious adverse event including severe dysphagia and vomiting. The device was removed from 4 of these 6 patients with a serious adverse event and in two others for persistent reflux and chest pain.
Five-year results from 33 of the 44 patients from the feasibility IDE trial were published in 2015. (13) For the 33 with follow-up, the mean total GERD-HRQL score decreased from 25.7 at baseline to 2.9 at year 5 (p<0.001); 93.9% had more than 50% reduction in total score vs baseline. On esophageal pH testing, the mean percentage of time that pH was less than 4 decreased from 11.9% at baseline to 4.6% at 5 years (p<0.001). At 5 years, 87.8% had stopped PPIs.
Five-year results for the 100 patients in the pivotal IDE trial were published by Ganz et al. (2016). (14) Eighty-five patients had follow-up at 5 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 average daily dose of PPI (95% CI, 81% to 95%). No new major safety concerns emerged. The device was removed in 7 patients.
In 2013, Bonavina et al. published longer follow-up from patients in the pilot and multicenter registry studies. (15) This study included a consecutive series of 100 patients who received MSA for GERD at their institution and were followed for a median of 3 years (range, 378 days to 6 years). Thirty of the patients had data beyond 5 years. Median GERD-HRQL score improved from 24 off PPIs to 2 (p<0.001), and freedom from daily dependence on PPIs was achieved in 85% of patients. The time that esophageal pH was less than 4 decreased from 8.0% to 3.2% (p<0.001). Although 3 patients had the device removed for persistent GERD, odynophagia, or dysphagia, no occurrences of device migrations or erosions were observed during follow-up.
In 2015, Lipham et al. reported on adverse events for the first 1048 implanted patients (82 institutions). (16) Of these, 144 were implanted as part of premarket clinical trials (previously described), 332 had been enrolled in the postmarket registry, and 572 were implanted outside of a postmarket registry. The three sources used to identify adverse events were the published clinical literature along with the device’s Summary of Safety Effectiveness Data, the Food and Drug Administration database for device-related complications (MAUDE database), and information provided by the manufacturer. Event rates were 0.1% intra- or perioperative complications, 1.3% hospital readmissions, 5.6% endoscopic dilations, and 3.4% reoperations for device removal. The primary reason for device removal was dysphagia. Erosion of the device occurred in 1 (0.1%) patient. Median device implantation was 274 days. This study was limited by the short follow-up and the voluntary reporting of adverse events outside of the registry.
Additional single-arm observational studies have reported on outcomes after MSA in sample sizes ranging from 121 to 192 patients, (17-20) some of which focused on specific subpopulations of individuals with GERD, such as those with large hiatal hernias (e.g., Rona et al. ). (20)
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. 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. Ninety-one percent of those who received the surgery were able to maintain discontinuation ofproton pump inhibitor (PPIs) at sixmonths. 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. (21)
Summary of Evidence
For individuals who have gastroesophageal reflux disease (GERD) who receive magnetic sphincter augmentation (MSA), the evidence includes one randomized controlled trial comparingMSAto proton pump inhibitortherapy, prospective and retrospective observational comparative studies, 2 single-arm interventional trials, and a number of single-arm observational studies. Relevant outcomes are symptoms, change in disease status, medication use, and treatment-related morbidity. In the 2 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-HRQL scores and reduced proton pump inhibitor use. Similarly, observational comparative studies, most often comparing MSA with laparoscopic Nissen fundoplication, generally have shown that GERD-HRQL scores do not differ significantly between fundoplication and MSA, and patients can reduce proton pump inhibitor use after MSA. Arandomized controlled trial comparing MSA to omeprazole 20 mg twice daily foundsignificantly more patients who received MSA reported improvements in symptoms and quality of life at six months. The evidence is sufficient to determine the effects of the technology on health outcomes.
Practice Guidelines and Position Statements
Society of American Gastrointestinal and Endoscopic Surgeons
In 2017, the Society of American Gastrointestinal and Endoscopic Surgeons published guidelines on the safety and effectiveness of the LINX Reflux Management System. (22) 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 GERD.
American Society for Gastrointestinal Endoscopy
A 2013 report from the American Society for Gastrointestinal Endoscopy concluded that long-term data on the safety and efficacy of the LINX device were needed. (23) The document indicated that the LINX band is currently being deployed laparoscopically; however, a natural orifice transluminal endoscopic surgery approach could be explored.
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 3.
Table 3. Summary of Key Trials
RELIEF Study: A Prospective, Multicenter Study of REflux Management With the LINX® System for Gastroesophageal REFlux Disease After Laparoscopic Sleeve Gastrectomy
Registry of Outcomes From AntiReflux Surgery (ROARS)
A Post-Approval Study of the Lynx® Reflux Management System
NCT: national clinical trial.
a Denotes industry-sponsored or cosponsored trial.
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|9/15/2021||Reviewed. No changes.|
|1/1/2021||Document updated with literature review. Coverage unchanged. Added references 1, 2, and 21.|
|4/1/2019||Reviewed. No changes.|
|5/1/2018||Document updated with literature review. Coverage unchanged. References 1-2, 11-12 and 15-19.|
|12/1/2017||Reviewed. No changes.|
|6/1/2017||Document updated with literature review. The following statement was added to the coverage section of the medical policy: Removal of an esophageal sphincter augmentation device may be considered medically necessary when all the following criteria are met: 1) Patient met all the criteria for initial placement of the device, AND 2) Complications such as erosion, device migration, or difficulty swallowing.|
|4/1/2016||New medical document originating from a topic previously addressed on medical policy MED201.016. Coverage has changed to the following: 1) A laparoscopically implantable magnetic esophageal ring (LINX™ Reflux Management System) is considered medically necessary as a treatment alternative to laparoscopic Nissen fundoplication when the patient has chronic gastroesophageal reflux disease (GERD) symptoms refractory to maximum medical therapy, 2) The safety and effectiveness of a laparoscopically implantable magnetic esophageal ring (LINX™ Reflux Management System) has not been established and/or is contraindicated and therefore considered experimental, investigational and/or unproven for patients with the following conditions: Suspected or known allergies to metals such as iron, nickel, titanium, or stainless steel; Hiatal hernias greater than 3 cm in size; Barrett's esophagus or Grade C or D (LA classification) esophagitis; 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 a known motility disorder (e g. 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), or Age <21.|
|Title:||Effective Date:||End Date:|
|Magnetic Esophageal Ring to Treat Gastroesophageal Reflux Disease (GERD)||09-15-2021||06-14-2022|
|Magnetic Esophageal Ring to Treat Gastroesophageal Reflux Disease (GERD)||01-01-2021||09-14-2021|
|Magnetic Esophageal Ring to Treat Gastroesophageal Reflux Disease (GERD)||04-01-2019||12-31-2020|
|Magnetic Esophageal Ring to Treat Gastroesophageal Reflux Disease (GERD)||05-01-2018||03-31-2019|
|Magnetic Esophageal Ring to Treat Gastroesophageal Reflux Disease (GERD)||12-01-2017||04-30-2018|
|Magnetic Esophageal Ring to Treat Gastroesophageal Reflux Disease (GERD)||06-01-2017||11-30-2017|
|Magnetic Esophageal Ring to Treat Gastroesophageal Reflux Disease (GERD)||04-01-2016||05-31-2017|