A: The LINX Reflux Management System is a laparoscopically implanted FDA-approved device. The system is based on a flexible bracelet made of magnetic titanium beads that, when worn around the esophagus, helps to support a weak lower esophageal sphincter (LES), the muscle that opens and closes to allow food to enter and stay in the stomach by restoring the body’s natural barrier to reflux.
A: There are risks involved with all surgical procedures, such as anesthetic risks, bleeding risks, and infection risks. These are minor dangers. The LINX system’s most common adverse effects include difficulty swallowing, post-operative discomfort, and transient stomach bloating. Many surgeons are concerned that the device will dissolve into the esophagus and would need to be removed in the long term. To yet, no evidence of this has been found in clinical trials.
A: The operation takes about an hour to perform on average. Because each case is unique, there is some variation in the time it takes to complete the treatment.
A: You will be kept in the hospital overnight after the procedure to ensure that there are no issues from the surgery or anesthetic.
When pain medication is no longer needed, routine daily activities can begin within a few days of surgery. Activities that require the use of the abdominal muscles, such as sit-ups or weight lifting, should be avoided for three to six weeks.
A: Only 10% of LINX patients required daily medicine at one- and two-year follow-up, according to clinical trials conducted prior to FDA approval of the device.
A: Yes; approximately 3% of individuals who had the device implanted experienced this issue, necessitating the gadget’s removal.
A: When a foreign object is implanted in the body, whether it’s LINX, a pacemaker, or an artificial joint, there’s always the potential of infection. At this moment, there isn’t enough information to calculate the percent chance of infection, although preliminary evidence suggests it’s low.
A: This gadget is intended to be permanent. However, we can’t be certain because no 10-year follow-up data is available yet.
A: An MRI creates images with very strong magnets, and the LINX system is subject to magnetic force. If the LINX device was in place during an MRI, you could sustain serious injuries.
A: Like persons who have a pacemaker or an artificial hip, all patients are issued a card saying that they have an implanted medical device.
Q: If I gain a lot of weight after the treatment, is there a danger the LINX system won’t perform as well?
A: The LINX system operates by applying pressure to the gastroesophageal junction of about 25 mm (the place where the esophagus and stomach meet). Because weight gain raises the pressure inside the belly, it’s likely that severe weight gain will create more pressure than the LINX valve can handle, causing reflux symptoms to reappear.
A: Antireflux surgery is covered by almost all insurance providers. Insurers are learning about the LINX operation because it is a novel type of antireflux surgery. On a case-by-case basis, we’re working closely with them to secure pre-authorization for these treatments.
Q: I’ve heard that I’m not eligible for LINX because I had bariatric surgery. Is it feasible that this may change in the future, and I will be qualified for the system?
Patients who have had previous bariatric or esophageal surgery are not eligible to use the LINX system.
Q: Can I have a conventional Nissen fundoplication (NF) if the LINX device needs to be removed or isn’t working?
A: Patients frequently remark that an NF was previously recommended to them or that they were considering it when they learned about LINX. Because the screening tests for both operations are the identical, NF may still be considered if testing does not rule you out. If you can’t or don’t want to use LINX, NF may be a viable alternative.
Q: I’m aware that I have GERD and that taking meds helps me feel better. Why am I required to undergo additional tests prior to the procedure?
A: It’s critical to know and document that the muscles in the esophagus that cause peristalsis provide enough pressure to open the LINX magnetic ring if you want to strengthen the lower esophageal sphincter. Esophageal motility testing is used to determine this. Although 24-hour pH testing is not required in all individuals, it is frequently required to demonstrate that your symptoms are linked to genuine reflux occurrences.
How much does Linx surgery cost with insurance?
BALTIMORE, MARYLAND 3 APRIL 2019 According to a new study presented today at the 2019 Annual Meeting of the Society of American Gastrointestinal and Endoscopic Surgeons, treatment with Ethicon’s** LINX Reflux Management System reduced medical costs more than laparoscopic Nissen fundoplication (LNF), a more invasive anti-reflux surgery, and more than offsets the slightly higher cost of the procedure (SAGES 2019). The study was conducted in conjunction with Highmark Health’s VITAL Innovation Platform, a test-and-learn environment for health innovations, and was partially funded by Ethicon, a subsidiary of Johnson & Johnson Medical Devices Companies**.
“According to main researcher Blair Jobe, MD, Director, AHN’s Esophageal and Lung Institute, “the higher initial cost of a LINX treatment compared to a Nissen fundoplication is regarded as a downside by insurers, which made securing insurance approvals challenging.” “When you consider in the higher reductions in medical expenditures following the procedure, this study implies that perception may be short-sighted in that insurance companies can provide better care for their GERD patients at a similar cost to laparoscopic Nissen fundoplication.”
The prospective observational study was conducted in collaboration with Highmark Inc., the region’s largest health insurance business, at Highmark Health’s Allegheny Health Network (AHN), a health system serving western Pennsylvania. The entire treatment cost, as well as disease-related and overall medical claim costs, were compared 12 months before and after a LINX (180 patients) or LNF operation (1,131 patients).
The average PMPM (per member per month) medical reimbursement claims linked to upper gastrointestinal (GI) disorders reduced by 66 percent ($305 to $104) after LINX, compared to 46 percent ($233 to $126) after LNF, according to the study. Overall, PMPM medical reimbursement claims for LINX patients declined by 10.7%, but only by 1.4 percent for LNF patients. Proton pump inhibitors (PPIs), acid suppression medications for gastrointestinal reflux disease (GERD), saw a 95% decline in reimbursements after LINX and a 90% drop after LNF.
The median cost of a LINX treatment was $13,522 (mean $14,379), whereas the median cost of an LNF procedure was $13,388 (mean $13,691), a difference that researchers believe is offset or surpassed by a reduced cost of care for the insurer in the year after surgery.
LINX is a minimally invasive technique that involves doctors wrapping a flexible ring of small magnets around the lower part of the esophagus, the body’s natural barrier to reflux. When a patient swallows, the magnetic ring stretches to enable food into the stomach, but contracts to prevent stomach contents from flowing back into the esophagus and triggering GERD, a disorder that affects around 20% of Americans. To assist prevent acid from flowing up into the esophagus, a surgeon wraps a section of the upper stomach (fundus) around the lower part of the esophagus in LNF.
“According to Tom O’Brien, President, Worldwide Endomechanical, Ethicon, “this study indicated that the LINX System is cost effective and should be more extensively covered by insurers.” “Ethicon will continue to support research that will help doctors, patients, insurers, and health systems make the best decisions possible about which therapies work best for which patients and at what cost.”
In previous LINX studies, 88 percent of patients said that painful heartburn had gone away five years after treatment, 85 percent were no longer on daily reflux medication, and 99 percent of patients had no regurgitation, a frequent GERD symptom. Patients’ quality of life has also improved significantly.
We’re building on a century of experience as the world’s most complete medical device company, combining science and technology to define the future of health and benefit even more people across the world.
We’re trying to fundamentally improve the way care is delivered by leveraging our unrivaled breadth, depth, and reach across surgery, orthopaedics, vision, and interventional treatments. We’re in it for the long haul.
The LINX Reflux Management System is a fundic-sparing laparoscopic anti-reflux procedure for patients who have been diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing and are looking for an alternative to continuous acid suppression therapy (proton pump inhibitors or equivalent) in the management of their GERD.
Patients with suspected or known sensitivities to titanium, stainless steel, nickel, or ferrous materials should not have the LINX Reflux Management System implanted.
Failure to correctly secure the LINX device may result in its displacement, necessitating a second procedure.
Precautions in General: The LINX device is a long-term implant. At any point, explant (removal) and replacement surgery may be necessary. Explantation and/or replacement may be used to treat undesirable responses.
In patients with a hiatal hernia bigger than 3 cm, the LINX device should be combined with hiatal hernia repair to reduce the hernia to less than 3 cm. The LINX device has not been tested in individuals with a hiatal hernia bigger than 3 cm that has not been corrected.
Patients with Barrett’s esophagus or Grade C or D (LA classification) esophagitis have not been studied to see if the LINX device is safe and effective.
The LINX device’s safety and effectiveness have not been tested in individuals who have electrical implants like pacemakers and defibrillators, as well as other metallic abdominal implants.
For the following circumstances, the LINX Reflux Management System’s safety and effectiveness have not been established:
- peristaltic amplitude less than 35 mmHg on wet swallows or distal esophageal motility less than 35 mmHg
- Gross esophageal anatomic anomalies (Schatzki’s ring, obstructive lesions, etc.) or esophageal stricture
Adverse reaction to anesthesia (headache, muscle pain, nausea), anaphylaxis (severe allergic reaction), cardiac arrest, death, diarrhea, fever, hypotension (low blood pressure), hypoxemia (low oxygen levels in the blood), infection, myocardial infarction, perforation, pneumonia, pulmonary embolism (blood clot in the lung), respiratory distress, and thrombophlebiti are all possible side effects of laparoscopic surgery and anesthesia (blood clot). Bloating, nausea, dysphagia (difficulty swallowing), odynophagia (painful swallowing), retching, and vomiting have all been recorded as side effects of anti-reflux surgery.
Achalasia (where the lower part of the esophagus does not relax), bleeding, cough, death, decreased appetite, device erosion, device explant/re-operation, device failure, device migration (where the device does not appear to be at the implant site), diarrhea, dyspepsia (indigestion), dysphagia (difficulty swallowing), early satiety (feeling full after eating a small amount of food), esophageal spasms (including but not limited to dysphagia or heartburn).
*Ethicon represents Ethicon, Inc., Ethicon Endo-Surgery, LLC, and certain of their affiliates’ goods and services.
**Includes the Johnson & Johnson Medical Devices segment’s surgery, orthopaedics, vision, and interventional businesses.
https://www.niddk.nih.gov/health-information/digestive-diseases/acid-reflux-ger-gerd-adults/definition-facts
According to a five-year prospective, multi-center, single-arm trial including 100 patients who were implanted with LINX, painful heartburn was 89 percent at baseline and 11.9 percent at five years. (p
What insurance covers Linx?
Torax Medical, a privately held medical device business that develops and produces solutions to treat sphincter diseases, made a stunning announcement nearly two years ago that rocked the Gastroenterology world. Health Care Service Corporation, the fourth largest commercial health insurer in the United States, began offering medical coverage for the LINX Reflux Management System on April 1, 2016. It was a big victory for the world of GERD, where doctors and patients had fought for years to get the Linx operation covered by insurance companies.
The LINX Reflux Management System, or LINX, is a ring of titanium-wrapped magnets that tightens and rings the lower esophagus, helping to keep food, bile, and stomach acid down. The magnetic attraction between the beads keeps the sphincter barrier in place and prevents reflux. The gadget, which is implanted utilizing minimally invasive laparoscopic surgery, was unanimously approved by the FDA in 2012. However, getting insurance companies to approve it was more difficult.
For a long time, insurance coverage has been a major source of controversy in the reflux community. The Linx surgery was previously covered by Medicare, but despite the fact that Linx has been on the market for four years, most private insurance companies refused to offer a medical coverage policy for the procedure. Needless to say, it was a tremendous cause of dissatisfaction for both patients and physicians, especially since most insurances cover even more invasive anti-reflux operations.
Commercial insurance companies initially argued that the LINX Reflux Management System was still “investigational” and “too new to cover” despite the FDA’s unanimous clearance. They needed additional time to see how the device compared to other anti-reflux options including the Nissen fundoplication operation, which involves wrapping a section of the patient’s stomach around the lower portion of the esophagus to create a reflux barrier.
It appeared that the commercial insurance sector was finally coming around after four years of overwhelming data establishing the LINX Reflux Management System as an effective, cost-effective, minimally intrusive therapy for severe instances of persistent GERD. The LINX procedure is now available to over 15 million patients through Health Care Service Corporation’s member organizations as a result of the new medical coverage policy (Blue Cross & Blue Shield of Illinois, BCBS of Montana, BCBS of Oklahoma, and BCBS of Texas).
Finally, the American Medical Association designated the LINX Reflux Management System for esophageal sphincter augmentation as a new Category 1 Current Procedural Terminology (CPT) Code in November 2017. The LINX method was designated as a first-line, minimally invasive therapy option for GERD.
There is still much work to be done before commercial insurance carriers provide LINX the coverage it deserves across the board, but this is a huge step in the right direction. We can only hope that more corporations recognize the benefit LINX provides to individuals with chronic GERD, and that we continue to work towards the day when medically required procedures such as LINX are covered for all patients.
Do I qualify for Linx surgery?
LINX has a very high success rate. Ninety to ninety percent of patients who undergo this treatment are able to totally cease using their medications, while the remaining five to ten percent only require them occasionally. There are also a number of advantages to this technique over earlier GERD treatments. The recovery time is usually short, and patients are usually able to return home the same day. Patients are also urged to eat immediately following the LINX operation, whereas previous surgical techniques required patients to adhere to a liquid diet for up to two weeks.
Patients who are 21 years old or older and in good enough condition to undergo surgery may be eligible for LINX. To establish their candidacy, all patients must undergo pre-surgical testing. These tests include the following:
Esophageal motility testing to see if the esophagus is the real culprit in GERD.
Does Medicare cover the Linx surgery?
Is LINX covered by insurance? Patients are approved for LINX on a case-by-case basis by insurance companies and Medicare. Your surgeon will begin the approval process once you have completed your pre-tests and are a candidate for LINX.
Why is the Linx so expensive?
Many people wonder why LINX surgery costs more than fundoplication surgery. The basic explanation is that it is because of the LINX device’s price.
The consulting fees, operating time, ward time, and other charges are all around the same for each. Because LINX is more expensive than fundoplication, it may be one of the reasons why so few NHS Trusts provide it.
The device alone costs almost £3,000, which may seem excessive for such a small item that fits in the palm of your hand, however there are multiple reasons for this:
- The engineering – Each gadget is meticulously engineered and built to medical-grade standards, with the intention that it will last a lifetime.
- The most expensive part is certainly research and clinical trials. It takes many years to develop a technique from the moment a concept is first conceived and then to evaluate the technology for both safety and efficacy. This necessitates a significant expenditure on the part of the device manufacturer, which can only be recouped over a long period of time and with no guarantee of success.
For the vast majority of reflux surgery patients, LINX is currently considered the best surgical option. It is not only minimally invasive, with a quick recovery time and prompt return to a normal diet, but it also provides great symptom relief. These gains happen rapidly after surgery, and current research shows that they last for a long time.
If you believe that reflux surgery is the best method to permanently control your reflux, we would be delighted to meet with you for a private consultation. This can be done by filling out the form below.
Is there surgery for acid reflux?
A Nissen fundoplication is a surgical procedure that is used to treat gastroesophageal reflux disease (GERD). A surgeon creates a sphincter (tightening muscle) at the bottom of the esophagus to prevent acid reflux during the procedure. After surgery, most people find a considerable reduction in acid reflux symptoms.
Who is not a candidate for Linx?
Patients must first undergo a thorough examination that includes upper gastrointestinal (GI) endoscopy and physiologic tests such as esophageal motility testing before contemplating the LINX surgery. The LINX technique is not recommended for patients with poor esophageal peristalsis or hiatal hernias bigger than 2 cm. The technique itself does not necessitate any preparation.