***There was a RECALL notice for certain devices as of May 2018.***
The information for it can be found here: RECALL NOTICE: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163588
The FDA approved the LINX method in 2012, according to the documents below,
I am not familiar with this medical equipment or procedure yet, so I wanted to research it for those of you out there who may not have heard of it yet, as it might help you. According to Healio Gastroenterology,
"LINX Reflux Management
Give Us a Call
For more information about LINX reflux management at MUSC,
call: Mary Johnson, RN
(843) 876-3090 or
johnsome@musc.edu
A patient suffering with gastroesophageal reflux disease (GERD) normally experiences frequent heartburn, regurgitation and/or nausea in the mid-chest region. This can cause severe discomfort and negatively impact the patient's quality of daily life.
If you are a reflux patient, 21 years of age or older, who still experiences significant GERD-related symptoms despite taking medication(s), you may be interested in the LINX® Reflux Management System.
LINX provides an option for patients who are taking acid-suppressing drugs (i.e. Prevacid®, Nexium®, Prilosec®, etc.) but are not getting their desired results. These types of medications help control acid build-up, but they cannot repair the underlying problem.
A color illustration of the lower esophagus and upper stomach showing placement of a small band of magnetized titanium beads wrapped around the lower esophageal sphincter.
What is LINX?
The LINX Reflux Management System (developed by Torax Medical, Inc.) is a permanent, drug-free treatment for GERD that consists of a small band of magnetized titanium beads wrapped around the lower esophageal sphincter (LES) located at the base of the esophagus. This band helps prevent gastric acids from pushing back up into the esophagus from the stomach, yet also safely allows the LES to open when required to allow for easy swallowing.
When a person with the LINX system installed swallows, the motion of food or drink passing through the lower esophagus overcomes the magnetic attraction between the beads permitting the contents to pass through the LES into the stomach. When the stomach reacts and reflux tries to escape up the esophagus (which would then result in heartburn), the magnetic beads keep the acid down in the same manner as a normally functioning LES.
This procedure can help patients return to a normal lifestyle unaffected by their GERD."
Source:http://ddc.musc.edu/public/surgery/laparoscopic/linx.html
Source:http://ddc.musc.edu/public/surgery/laparoscopic/linx.html
According to RefluxMD,
"Ten things you need to know about LINX
By Dr. Dengler
Last updated on November 15th, 2018 at 02:23 pm
This Article is Written and/or Reviewed by RefluxMD Medical Authors Team and Reviewers
One out of three Americans suffer from heartburn symptoms. Many of those sufferers have gastroesophageal reflux disease (GERD) and they don’t even know it.
Until recently the only cure was a surgical procedure known as 'Nissen fundoplication,' which has the potential to cause side effects that lead many to delay or avoid surgery. Last year, the Food and Drug Administration approved a new treatment device called the LINX Reflux Management System to offer a new approach to treating GERD, a disease that is increasing at a rate of 30 percent every decade.
Paul Taiganides, M.D., is the medical director of the Knox Regional Heartburn Treatment Center at Knox Community Hospital in Mount Vernon, Ohio. Dr. Taiganides and Knox Community Hospital were one of 14 locations selected to participate in the initial US clinical trials for the LINX device. Since then, Dr. Taiganides has performed more LINX procedures than any other U.S. surgeon. The center has done more than 700 Nissen fundoplication surgical procedures in the last seven years. Recently, he has trained surgeons in the LINX technique at Harvard University and Northwestern University.
'I was recommended to the LINX by Tom DeMeester [M.D.] and William Dengler [M.D.], medical advisors to RefluxMD. Dr. DeMeester is the recognized global leader on reflux disease and a senior medical advisor to Torax Medical, the innovator behind the LINX System,' said Dr. Taiganides. 'This is the first advancement in the surgical treatment of GERD in 50 years — and I believe this small titanium band will have a huge impact on how we surgically treat reflux disease.'
Here are 10 things you need to know about the LINX procedure.
No. 1: It is focused on the underlying cause of reflux disease not the side effect.
Reflux disease is a result of a damaged lower esophageal sphincter (LES). The LES is a muscle that is constantly closed, but allows food and liquid to pass into the stomach. When the LES loses its strength, acidic stomach juices can back up into the esophagus creating the painful symptom of heartburn. The LINX device wraps around the LES, augmenting it to prevent reflux.
No. 2: It is safer than the long-term use of proton pump inhibitors (PPIs).
PPIs only treat symptoms. More importantly, studies have proven that reflux disease can progress even when PPI therapy has effectively eliminated GERD symptoms. Furthermore, daily PPI use has been associated with Barrett’s Esophagus, a pre-cancerous condition, an increase in bone fractures, a higher risk of pneumonia, an increased incidence of C. difficile intestinal infections, and increased risk of heart arrhythmias.
No. 3: LINX is effective at reducing symptoms and improving quality of life.
A recent study published in the New England Journal of Medicine tracked 100 patients for three years after their LINX surgery. That study found an overall decrease in stomach contents reaching the esophagus, fewer reflux symptoms, and a substantial reduction in PPI usage.
No. 4: The side effects disappear over time in most cases.
Initially, most patients experience some discomfort, but it typically dissipates over several weeks. In addition, the most commonly reported side effect is mild difficulty swallowing, which usually subsides over time.
No. 5: The cost of the device is approximately $5,000.
Surgery costs between $12,000 and $20,000. A traditional Nissen fundoplication surgical procedure is estimated in excess of $18,000. The cost can be much less than a lifetime of PPI use: a 2010 study by Consumer Reports found once-a-day PPI use can range from $2,000 to $4,500 per year for brand name prescription PPIs.
No. 6: There are very few physicians performing the LINX procedure.
Like all surgical procedures, a surgeon’s proficiency is largely dependent upon the number of procedures performed each year. Torax Medical has been very selective in choosing their surgeons seeking the most experienced physicians available.
No. 7: This is minimally invasive and is performed as an out-patient procedure.
The LINX procedure is usually completed in less than one hour. After the use of general anesthesia, small surgical instruments and a video camera are used in this laparoscopic procedure. Within 24 hours most patients return to a normal diet although there is some difficulty getting used to a functioning LES. These difficulties typically subside in 10 to 15 days and most patients report no symptoms after two or three months.
No. 8: LINX is reversible and can be replaced.
Since the LINX band is placed around the LES, the device can be removed or replaced, if necessary. This requires a surgical procedure, and Dr. Taiganides noted that this has not been necessary for any of his patients.
No. 9: This procedure is recommended for those with continued GERD symptoms under maximum therapy prescribed by a specialist.
I agree with Dr. DeMeester that a reflux disease has defined stages. Early stages must be treated with diet and lifestyle changes along with intermittent drug therapy. When these therapies fail to manage GERD symptoms impacting daily activities or sleep, the LINX System should be considered as an option.
No. 10: LINX is not for everyone with advanced GERD.
Today LINX is not approved for those with Barrett’s Esophagus or anyone suffering from esophageal cancer. It is important for everyone suffering from advanced stages of reflux disease to explore all available options before their disease progresses to the point where options are limited.
It is important to take your heartburn symptoms seriously because it is a signal from your body that something is wrong. Since reflux disease is a progressive chronic condition, you need to make the necessary changes before you have to schedule a surgery."
Business Wire says,
"Torax Medical Announces FDA Approval of a New LINX® Device Compatible with 1.5 Tesla Magnetic Resonance Imaging (MRI) Systems
New LINX Device expands patients’ diagnostic imaging options after treatment
ST. PAUL, Minn.--(BUSINESS WIRE)--Torax Medical, Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved a next generation LINX® Reflux Management System that is MR conditional in magnetic resonance imaging (MRI) systems up to 1.5 Tesla (1.5T), which represents about 90% of MRI systems in use in the U.S. The LINX 1.5T design contains a different grade of magnets that have a higher resistance to being demagnetized when subjected to external magnetic fields (i.e. MRI).
'We are pleased to make this next generation LINX device available to patients seeking relief from their reflux symptoms while broadening their access to diagnostic imaging options after treatment,' said Todd Berg, President and CEO of Torax Medical.
Patients considering the LINX procedure should consult their healthcare provider regarding any questions related to MR imaging. Patients who have already received a LINX implant should consult their provider prior to undergoing any MRI tests. Information on diagnostic imaging options with LINX is also available at www.linxforlife.com and www.toraxmedical.com.
The Disease
Gastro-esophageal Reflux Disease (GERD) is a chronic, often progressive disease resulting from a weak lower esophageal sphincter that allows harmful gastric fluid to reflux into the esophagus, resulting in both pain and injury to the esophageal lining. GERD is associated with a pre-cancerous condition known as Barrett’s esophagus, which increases the risk of esophageal cancer. Symptoms of GERD include heartburn and regurgitation, often associated with chronic sleep disruption, and may also include persistent cough, excessive throat clearing, hoarseness and a feeling of a “lump” in the throat. Acid reflux medications, such as Prevacid®, Nexium®, and Prilosec®, affect gastric acid production, but do not repair the sphincter defect, allowing continued reflux. The FDA has issued a series of statements on possible side effects of long-term PPI use including: possible fracture risk, low magnesium levels, and clostridium difficile-associated diarrhea. More recently, a study out of Stanford University published in the journal PLOS ONE showed PPI use may increase the risk of heart attack.1 The alternative surgical option to LINX is Nissen fundoplication. Nissen fundoplication reconstructs a new reflux barrier using a portion of the patient’s stomach, which is wrapped around the lower portion of the esophagus.
The LINX Reflux Management System
LINX is a small implant comprised of interlinked titanium beads with magnetic cores. The magnetic attraction between the beads augments the existing esophageal sphincter’s barrier function to prevent reflux. The device is implanted using a standard minimally invasive laparoscopic procedure and is an alternative to the more anatomically disruptive fundoplication, commonly used in surgical anti-reflux procedures. The LINX Reflux Management System is indicated for those patients diagnosed with GERD as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.
LINX does require a surgical procedure and is associated with potential risks, contraindications and life style modifications. For more information on LINX, including a statement of risks, please visit www.linxforlife.com.
About Torax Medical
Torax Medical, Inc. is a privately-held medical device company headquartered in St. Paul, Minnesota that develops and markets products designed to treat sphincter disorders utilizing its technology platform, Magnetic Sphincter Augmentation (MSA). Torax Medical is currently marketing the LINX® Reflux Management System for the treatment of GERD in the U.S. and Europe and the FENIX® Continence Restoration System for the treatment of Fecal Incontinence (FI) in Europe. For more information, please visit www.toraxmedical.com.
1PLOS ONE DOI:10.1371/journal.pone.0124653
Contacts
Torax Medical, Inc.
Maggie Wallner, 651-361-8900
info@toraxmedical.com"
According to Sages the company who was in charge of the study,
"LINX® REFLUX MANAGEMENT SYSTEM
March 13, 2017 by SAGES Webmaster
SAGES Technology and Value Assessment Committee (TAVAC) Safety and Effectiveness Analysis
LINX® Reflux Management System (Torax Medical, Inc.)
SAGES LINX® Safety and Effectiveness Analysis Committee
Dana Telem, MD, MPH
Andrew Wright, MD
Paresh Shah, MD
TAVAC Committee Chair: Matthew Hutter, MD, MPH
About this update
The original SAGES LINX Safety and Efficacy Analysis (SEA) was completed and published online in 2013. The literature presented in this first document was based on the pre-market and the initial post-market experience that had been published in the peer reviewed literature at the time. In the 3 years that have passed since the original SAGES Technology and Value Assessment Committee (TAVAC) LINX SEA was published, sufficient new data has become available to necessitate an update and a fresh look at the SAGES recommendations with regards to this technology.
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.
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. In contrast to fundoplication, patients are started on a solid diet soon after the procedure.
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. The immediate post-approval version of the LINX device was only compatible with a magnetic resonance imaging device (MRI) up to 0.7T (Tesla). In June of 2015, the FDA approved the next generation of the device compatible and safe with an MRI up to 1.5 Tesla. The LINX System is contraindicated in patients receiving electrical implants such as defibrillators or pacemakers or undergoing insertion of metallic implants in the abdomen.
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].
FDA Instructions for Use (2012)
Indications
The LINX system is labeled for use in GERD patients with abnormal pH testing who continue to have chronic symptoms despite anti-reflux therapy.
Precautions (summary)
The LINX device has not been evaluated in patients with a hiatal hernia larger than 3-cm. Use of LINX device in patients with a hiatal hernia larger than 3-cm should be considered on the basis of each patient’s medical history and severity of symptoms.
The safety and effectiveness of the LINX device has not been evaluated in patients with Barrett’s esophagus or Grade C or D (LA classification) esophagitis.
The safety and effectiveness of the LINX device has not been evaluated in patients with major motility disorders.
The safety and effectiveness of the LINX Reflux Management System has not been established for the following conditions:
Scleroderma
Suspected or confirmed 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 (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. Morbid obesity (BMI >35).
Age <21 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) [2]. 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.
Source:https://fox4kc.com/sponsored/?prx_t=eK4CArO4NArSEKA&prx_ro=s
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. 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 [15]. 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 [16]. Laparoscopic 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 [17]. 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 [18,19]. Potential surgical side effects following Nissen fundoplication include difficulty swallowing, increased flatus, bloating, early satiety, and inability to vomit or belch [20,21]. Anatomic failure of the fundoplication with recurrent GERD can occur in 2-17% of cases [22].
The published outcomes of antireflux surgery are not always replicated in the community, especially for surgeons who perform laparoscopic antireflux surgery infrequently [23,24]. 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).” [25] 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 other 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. A 2013 SAGES Statement on Endoluminal Treatments for GERD focused on 2 endoluminal devices available at the time of the review – EsophyX (Trans Oral Fundoplication or TIF, Endogastric Solutions, Redmond, WA) and Stretta (Mederi Therapeutics, Norwalk, CT) and is available for review. [26]. Direct comparisons between LINX and other commercially available products are unavailable. Experience with endoluminal GERD treatments continues to evolve.
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 July 2016. The literature search used combinations of the keywords LINX, reflux, magnetic, magnetic sphincter augmentation, and/or GERD. Review articles without unique clinical data were excluded. Articles pertaining to the use of LINX in patients who have previously undergone bariatric surgery were considered outside the scope of this review and 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. Patients from the feasibility and the pivotal trial are included in many other case series and case-control series. Patients from the post-market experience at numerous centers are represented several times in more recent publications included in this updated review. All references are described in detail in Appendix A.
4. Safety and Efficacy Data
Summary Paragraph:
Review of published studies suggests that magnetic sphincter augmentation is safe with no reported deaths and a 0.1% rate of intra/perioperative complications [27]. Long-term efficacy of LINX appears good for typical GERD symptoms with reduced acid exposure, improved GERD symptoms, and freedom from PPI in 85-88% at 3-5 years [28,29,30]. The most common side effect is dysphagia, the rate of which likely differs based on definition and patient population. Early dysphagia within the first few weeks is common at about 70% [31,32]. Dysphagia resolves in most patients and the incidence is roughly 10% at 1 year and 4% at 3 years [31]. The need for endoscopic dilation ranges from 6-12% [27, 33] and the primary reason for explantation appears to be persistent dysphagia with a rate in larger series from 3-6% [27,28,31]. Erosion appear to be rare, with one case reported in the 1st 1,000 patients [27], one additional published case report [34], a large series reporting 2 erosions [35], and several additional reports in the FDA MAUDE dataset (true number unknown, as multiple entries in this dataset may be made for each patient). Based on very limited literature, erosion can be successfully treated with explantation. Initially there were concerns about safety of LINX in patients who might later need an MRI. Patients who underwent LINX implantation prior to May 2015 are limited to MRI under 0.7T, while patients who have LINX subsequent to that date may have MRIs up to 1.5T (Torax website).
Publication Review
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 33 in Europe). Four separate publications report results at 3-months [36],1 to 2 years [37], 4 years [38], and 5 years [30]. 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 process [2]. Three-year follow-up on the pivotal trial was published at the time of the first version of this document [31]. More recently, 5-year follow-up on the pivotal study cohort was published as well [29].
Bonavina et al. [36] 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. From this study, the authors suggest that in their experience laparoscopic implantation of the magnetic sphincter augmentation device is safe and well tolerated. They also propose that the short learning curve and minimal dissection required may be advantageous. Bonavina et al. [37] later 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.” Lipham et al. [38] followed this same patient cohort and 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.” Saino et al recently reported the 5-year outcomes of the feasibility trial cohort [30]. Of the original 44 patients, 33 were available for follow-up at 5-years. Mean total percentage of time with pH <4 was 11.9% at baseline and 4.6% at 5 years (P < .001), with 85% of patients achieving pH normalization or at least a 50% reduction. Mean total GERD-HRQL score improved significantly from 25.7 to 2.9 (P < .001) when comparing baseline and 5 years, and 93.9% of patients had at least a 50% reduction in total score compared with baseline. Complete discontinuation of PPIs was achieved by 87.8% of patients. No complications occurred in the longer term, including no device erosions or migrations. The authors conclude that based on long-term reduction in esophageal acid, symptom improvement, and no late complications, that they have demonstrated the relative safety and efficacy of magnetic sphincter augmentation for GERD. 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. [31] 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, these investigators 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. Ganz and colleagues later reported the 5-year outcomes for 85 of the 100 patients enrolled in the pivotal trial [29]. Over the follow-up period, no device erosions, migrations, or malfunctions occurred. At baseline, the median GERD-HRQL scores were 27 in patients not taking proton pump inhibitors, and 11 in patients on these medications. Five years after device placement this score decreased to 4. All patients used proton pump inhibitor medications at baseline and at 5 years these medications were only used in 15%. Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at 5 years. All patients reported the ability to belch and vomit if needed. Bothersome dysphagia was present in 5% at baseline and in 6% at 5 years. Bothersome gas-bloat was present in 52% at baseline and decreased to 8.3% at 5 years. The authors conclude that augmentation of the lower esophageal sphincter with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. Additional notable recent additions to the literature include a safety analysis of the first 1,000 patients implanted with a device [27]. Event rates were 0.1% intra/perioperative complications, 1.3% hospital readmissions, 5.6% endoscopic dilations, and 3.4% reoperations. All reoperations were performed non-emergently for device removal, with no complications or conversion to laparotomy. The primary reason for device removal was dysphagia. No device migrations or malfunctions were reported. Erosion of the device occurred in one patient (0.1%). The authors of this study concluded that with regards to safety, the overall event rates were low based on data from 82 institutions, and that the LINX device is a safe therapeutic option. Asti et al. [35] reported the results of a retrospective review of prospectively collected data examining the outcomes of 164 patients undergoing LINX implantation with median follow-up of 48 months. In eleven patients (6.7%), the device was ultimately removed for heartburn or regurgitation (n=5), dysphagia (n=4), or chest pain (n=2). In 2 patients, full-thickness erosion of the esophageal wall with partial endoluminal penetration of the device occurred. The estimated removal-free probability at 80 months was 0.91 [confidence interval (CI) 0.86–0.96]. The median implant duration was 20 months, with 82% of the patients being explanted between 12 and 24 months after the implant. Device removal was most commonly combined with partial fundoplication. There were no conversions to laparotomy and the postoperative course was uneventful in all patients. These authors conclude that laparoscopic removal of the LINX device “can be safely performed as a 1-stage procedure and in conjunction with fundoplication even in patients presenting with device erosion.”
There are several publications comparing clinical outcomes of the LINX device when compared to laparoscopic Nissen fundoplication. Louie et al. [39] compared perioperative outcomes, symptom control, side effects, adverse events, and pH studies in 34 consecutive patients who underwent LINX to 32 consecutive patients who had laparoscopic Nissen fundoplication. All patients with a hiatal hernia > 3-cm were excluded from this analysis. Operative time was longer for fundoplication. At 6 months, scores on the Gastroesophageal Reflux Disease Health Related Quality of Life scale improved from 20.6 to 5.0 for LINX vs. 22.8 to 5.1 for fundoplication. Postoperative DeMeester scores (14.2 vs. 5.1, p=0.0001) and the percentage of time pH was less than 4 (4.6 vs. 1.1; p=0.0001) were normalized in both groups. , but lower in the LINX group. LINX resulted in improved gas and bloat sensations (1.32 vs. 2.36; p=0.59) and enabled belching in 67% compared with none of the fundoplication patients. The investigators determined that LINX results in similar GERD symptom control with an improved quality of life compared to fundoplication.
Sheu et. al. [40] compared the outcomes of 12 patients to undergo LINX to 12 patients who had undergone laparoscopic Nissen fundoplication who were matched based on age, gender, and hiatal hernia size. LINX and Nissen fundoplication were both effective treatments for GERD. Severe dysphagia requiring endoscopic dilation was more common in LINX (50% vs. 0%; p=0.01). There was a non-statistically significant trend towards decreased gastrointestinal symptoms of bloating, flatulence, and diarrhea for LINX. These authors concluded that LINX and fundoplication are both effective and safe treatments for GERD. “Consideration to the distinct post-operative symptom profiles should be paid when selecting a surgical therapy for reflux disease.”
Riegler et al. [41] analyzed a prospective, multicenter registry of patients to undergo LINX and laparoscopic fundoplication for GERD. There were 202 LINX and 47 fundoplication patients with 1-year follow-up data at the time of their analysis. The fundoplication group was older with a greater frequency of large hiatal hernia and Barrett’s esophagus. GERD-health related quality of life score improved following surgery for both procedures. Moderate or severe regurgitation improved from 58.2 to 3.1% after LINX and 60.0 to 13.0% after fundoplication (p = 0.014).
Proton pump inhibitor medications were discontinued by 82% of LINX and 63.% of fundoplication patients (p = 0.009). Symptoms of excessive gas and abdominal bloating were reported by 10% of LINX and 32% of fundoplication patients (p ≤ 0.001). The authors of this study concluded that antireflux surgery should be individualized to the characteristics of each patient, taking into consideration anatomy and side effects. They felt that both LINX and fundoplication showed significant improvements in reflux control, with similar safety and reoperation rates. “In the treatment continuum of antireflux surgery, MSAD (Magnetic Sphincter Augmentation Device) should be considered as a first-line surgical option in appropriately selected patients without Barrett’s esophagus or a large hiatal hernia in order to avoid unnecessary dissection and preserve the patient’s native gastric anatomy.”
Reynolds was the lead author on 2 additional comparative studies evaluating LINX and fundoplication [42,43]. In the first comparative study to be published, from a series of 62 LINX and 117 laparoscopic Nissen fundoplications, 50 patients in both groups were matched using the “best-fit” model incorporating numerous preoperative variables. At 1 year after surgery, both groups had similar GERD Health Related Quality of Life scores and proton-pump inhibitor use. There were no patients with severe gas and bloating in the LINX group compared with 10.6% in the LNF group (p = 0.022). More fundoplication patients were unable to belch (8.5% of LINX and 25.5% of fundoplication; p = 0.028) or vomit (4.3% of LINX and 21.3% of fundoplication; p = 0.004). The incidence of postoperative dysphagia was similar between the groups. The authors concluded that analogous GERD patients had similar control of reflux symptoms with a lower incidence of gas bloat in LINX. In the second comparative trial by Reynolds et al, essentially the same cohort of patients was used to compare charges, complications, and outcome of LINX versus laparoscopic Nissen fundoplication at 1-year. There were 52 LINX and 67 fundoplication patients included. There was no significant difference between the mean charges. The fundoplication procedure was associated with a longer operative time and length of stay. Symptomatic outcomes and the ability to discontinue proton pump inhibitor medications were similar between procedures. As reported in the previously referenced publication, gas bloat as well as the ability to belch or vomit if needed was better following LINX. The authors concluded that fundoplication and LINX are comparable in symptom control, safety, and overall hospital charges.
Warren et. al. [44] published a multi-institutional retrospective cohort study of patients with GERD undergoing either LINX or laparoscopic Nissen fundoplication. Comparisons were made at 1 year for the overall group and for a propensity-matched group. There were 201 LINX and 214 fundoplication patients that were similar preoperatively with regards to age, gender, and GERD-HRQL scores. Obesity, dysphagia, higher DeMeester scores, Barrett’s esophagitis, and hiatal hernias were more prevalent in the fundoplication patients. Propensity-matched cases showed similar GERD-HRQL scores and the differences in ability to belch or vomit, and gas bloat persisted in favor of LINX. Mild dysphagia was higher for LINX (44 vs. 32 %, p=0.03). Resumption of daily PPIs was higher for LINX (24 vs. 12, p=0.02) with similar patient-reported satisfaction rates.
There was a trial at the Jacksonville, Mayo Clinic. This is what their description says,
Asti et al published another comparative study evaluating outcomes following LINX and laparoscopic Toupet fundoplication [45]. Using the propensity score full matching method and generalized estimating equation, consecutive patients undergoing laparoscopic Toupet or LINX over the same time period were compared. Over a 7-year period, 103 patients underwent a laparoscopic Toupet and 135 a LINX procedure. All patients had a minimum 1-year follow-up. Over time, patients in both groups had similar GERD-HRQL scores, gas-related symptoms, dysphagia, and reoperation-free probability. In 2 concurrent cohorts of patients with early stage GERD undergoing laparoscopic Toupet or LINX and matched by propensity score analysis, health-related quality of life significantly improved and GERD-HRQL scores had a similar decreasing trend over time up to 7 years of follow-up. The authors conclude that laparoscopic Toupet and LINX provide similar disease-specific quality of life over time in patients with early stage GERD.
A search of the ClinicalTrials.gov website identified 8 clinical trials sponsored by Torax Medical. Five of these studies (all observational) have been completed. A post-approval study of the LINX reflux management system (NCT01940185) is active but not recruiting. The primary outcome measure of this study is a successful reduction of GERD-HRQL scores and adverse events to 60 months. The estimated study completion date is September 2019. The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease (NCT02505945) is open for enrollment with an estimated study completion date of April 2017. This study compares mechanical sphincter augmentation (LINX Reflux Management System) to double-dose proton pump inhibitors (PPIs) for the management of reflux symptoms related to gastroesophageal reflux disease (GERD). The percentage of subjects with resolution of the GERD symptom of interest in each arm will be compared for significance. The final study is not yet recruiting. https://clinicaltrials.gov/ct2/results?term=torax+medical&cond=%22Gastroesophageal+Reflux%22 (accessed March 24, 2016)
A review of the FDA MAUDE database (3/1/12-2/29/16) revealed 141 reported adverse events (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/results.cfm). All 141 reports describe device explants. Over the entire post-FDA approval interval to date, there were 72 reports of devices removed for dysphagia primarily. There were 33 reports of devices removed for recurrent or persistent GERD. A total of 14 erosions are reported in the MAUDE database at the time of this search. It is not possible to determine the incidence of device removal or erosion from the MAUDE database as the denominator is not known, some events may be reported more than 1 time, and some are likely not reported at all.
There are 3 published case reports describing device removal at the time of this review. Dysphagia [46,47] and erosion [34] were the primary indications for device removal in these reports. Lipham [27] reported 1 erosion in 1,000 patients and Asti [35] reported 2 in 164 patients.
In November of 2015, the American Medical Association awarded the LINX device a new Category 1 CPT (Current Procedural Terminology) code that will be effective January 1, 2017.
The criteria for a category 1 CPT code are as follows (https://www.ama-assn.org/ama/pub/physician-resources/solutions-managing-your-practice/coding-billing-insurance/cpt/cpt-process-faq/code-becomes-cpt.page):
All devices and drugs necessary for performance of the procedure of service have received FDA clearance or approval when such is required for performance of the procedure or service
The procedure or service is performed by many physicians or other qualified health care professionals across the United States
The procedure or service is performed with frequency consistent with the intended clinical use (i.e. a service for a common condition should have high volume)
The procedure or service is consistent with current medical practice
The clinical efficacy of the procedure or service is documented in literature that meets the requirements set forth in the CPT code change application.
5. Limitations of currently published data
Patients used repeatedly in some publications
There may be a publication bias in favor of LINX, as several studies were either funded by the manufacturer or were performed by investigators affiliated with the manufacturer.
Most studies were performed in high volume centers in highly selected patients and may not reflect broader clinical practice, which may lead to underreporting of complications
Current studies lack randomization and blinding
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 anticipated side effect was acute dysphagia.
The reported rate of erosion is in the range of 0.1% to 0.2%. The published literature on erosions suggests that the device can be safely removed endoscopically or laparoscopically without serious adverse outcomes.
Some devices require removal, most often for recurrent GERD or persistent and/or severe dysphagia
No new patterns of failure or complications have been reported in long-term follow-up.
Longer-term follow-up supports the FDA conclusion that the device is safe.
With regards to efficacy, the panel concludes:
LINX implant results in pH normalization, improved quality of life, and complete cessation of regular PPI use on a consistent basis. The ability to belch and vomit is maintained following implantation of LINX, and de novo moderate-severe gas-bloat is uncommon.
When compared to laparoscopic fundoplication, rates of success in alleviating GERD symptoms and dysphagia are similar following LINX. Bloating side effects may be lower.
Longer-term follow-up data demonstrates that the LINX Reflux Management System is effective in the management of GERD.
Conclusions:
Longer-term (3-5 years) experience with the LINX Reflux Management System confirms the initial safety profile that led to FDA approval of the device.
The LINX device has been demonstrated to result in long-term GERD control based on symptomatic outcomes, PPI utilization, and pH studies.
LINX is a reasonable treatment option for appropriately selected patients with GERD who meet indications for antireflux surgery. The LINX procedure is part of the armamentarium in the treatment of GERD. As such, it should be performed by surgeons familiar with the workup and different management alternatives of GERD and not offered in isolation.
Implantation of the LINX device should be covered and reimbursed by insurance for appropriate patients who meet the selection criteria as described above.
Author Financial Disclosure/Conflict of Interest Statement
Dana Telem, MD: Research funding at Cook, Consulting Fees at Ethicon and Medtronic, Honoraria at Gore
Andrew Wright, MD: Honoraria at Medtronic.
Paresh Shah, MD: Consultant at Stryker, Zmicro, Olympus, Endoevolution
Matthew Hutter, MD: Reimbursed to attend Masters in MIS Forum by Olympus.
This document underwent prescreening review prior to submission to SAGES Board of Governors for approval by SD Schwaitzberg, MD and Patricia Sylla, MD
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