Longest Study of Magnetic Sphincter Augmentation Shows Durable Efficacy of Linx Reflux Management System

CINCINNATI - Nov. 10, 2020 - Ethicon*, part of the Johnson & Johnson Medical Devices Companies**, announced today its LINX^® Reflux Management System was shown to provide effective long-term control of gastroesophageal reflux disease (GERD) and eliminated the need for daily reflux medications in 79% of patients in the longest-term study ever published on magnetic sphincter augmentation (MSA).¹ The study, which followed patients over a 6- to 12-year period, recently appeared in the journal Nature Scientific Reports.² 

The LINX Reflux Management System is a flexible ring of small magnets placed around the lower part of the esophagus, the body's natural barrier to reflux, during a minimally invasive procedure. The magnetic ring expands when a person ingests food and then contracts to prevent stomach contents, including gastric acid, from backing up into the esophagus and causing GERD, a condition that affects about 20% of people in the United States.³

In the single-center (IRCCS Policlinico San Donato in Italy) retrospective study of 335 patients who had an MSA procedure with LINX between 2007 and 2020, 124 patients who had been implanted for at least 6 years and up to 12 (median 9 years) were followed. Nearly 90% of LINX patients experienced long-term favorable outcomes defined as a greater than 50% improvement in their GERD-health related quality of life (GERD-HRQL) score and the discontinued use of proton pump inhibitors (PPIs), the current standard of care in medical therapy.⁴ There were no device erosions or migrations and only three instances (2.4%) of device removal due to either continued reflux symptoms, dysphagia or the need for an MRI in this long-term group.² Patient satisfaction was 93.8% after 10 years.²

"Our new study corroborates the findings of previous studies but over a longer period of time, which is important for an implanted device," said study co-author Luigi Bonavina***, MD, Professor of Surgery at University of Milan School of Medicine and Chief of the Department of Surgery at IRCCS Policlinico San Donato. "The efficacy of the LINX System remained strong and the risk of complications did not increase many years after implantation. Based on these results and the high levels of patient satisfaction, MSA may represent a true paradigm shift that has the potential to fill the current therapy gap in GERD."

This latest study builds on more than 50 peer-reviewed articles,⁵ including a randomized clinical trial, that show procedures with the LINX System are more effective than twice-daily PPIs in normalizing reflux⁶ and more effective in reducing disease-related payer cost 12 months post-surgery than laparoscopic Nissen fundoplication, a more invasive anti-reflux surgery.⁷

Several GI and surgical societies, including the American Society of General Surgeons (ASGS), Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), the American College of Gastroenterology (ACG) and the American Foregut Society (AFS), have issued consensus statements in favor of LINX procedures for appropriate GERD patients.  

"Despite extensive clinical evidence, including this long-term study, and support from leading societies and academic centers, treatment with the LINX System remains out of reach for many patients due to inconsistent insurance coverage throughout the U.S.," said Tom O'Brien, Worldwide Endomechanical President, Ethicon. "We are committed to providing the clinical and economic evidence that insurance carriers demand so patients with severe GERD can finally have access to the long-term relief they need and the potential for an improved quality of life wherever they happen to live." 

About the LINX Reflux Management System
The LINX Reflux Management System is indicated for those patients diagnosed with GERD as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy. LINX requires a surgical procedure and is associated with potential risks, contraindications and lifestyle modifications. For more information about LINX, or to find a physician, visit www.linxforlife.com. LINX is manufactured by Torax^® Medical, Inc., 4188 Lexington Avenue North, Shoreview, Minnesota 55126, USA.

About Ethicon 
From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing healthcare issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. Learn more at www.ethicon.com, and follow us on Twitter and LinkedIn.

About the Johnson & Johnson Medical Devices Companies
The Johnson & Johnson Medical Devices Companies' purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, interventional and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.

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Media Contact:
Ann Leibson
aleibso@its.jnj.com
(513) 337-8180

Cautions Concerning Forward-Looking Statements 
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 the Linx Reflux Management System. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of [OPCO] [, any of the other Johnson & Johnson Medical Devices Companies] and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to: [uncertainty of regulatory approvals;] uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; [manufacturing difficulties and delays;] [product efficacy or safety concerns resulting in product recalls or regulatory action;] changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither [OPCO / the Johnson & Johnson Medical Devices Companies] nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. 

LINX^® Reflux Management System Important Safety Information

The LINX^® Reflux Management System is a laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD.
Rx Only 
Contraindications: Do not implant the LINX Reflux Management System in patients with suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
Warnings: The LINX device is considered MR Conditional in a magnetic resonance imaging (MRI) system up to either 0.7 Tesla (0.7T) or 1.5 Tesla (1.5T), depending on the LINX model implanted. Scanning under different conditions may result in serious injury to you and/or interfere with the magnetic strength and the function of the device. In the event alternative diagnostic procedures cannot be used and MRI is required, the LINX device can be safely removed utilizing a laparoscopic technique that does not compromise the option for traditional anti-reflux procedures. It is recommended that patients receiving the LINX device register their implant with the MedicAlert Foundation (www.medicalert.org) or equivalent organization. 
Failure to secure the LINX device properly may result in its subsequent displacement and necessitate a second operation. 
Laparoscopic placement of the LINX device is major surgery and death can occur. 
General Precautions: The LINX device is a long-term implant. Explant (removal) and replacement surgery may be indicated at any time. Management of adverse reactions may include explantation and/or replacement.
The use of the LINX device in patients with a hiatal hernia larger than 3 cm should include hiatal hernia repair to reduce the hernia to less than 3 cm. The LINX device has not been evaluated in patients with an unrepaired hiatal hernia greater than 3 cm. 
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 electrical implants such as pacemakers and defibrillators, or other metallic, abdominal implants. 
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 High Resolution Manometry equivalent, and/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
• Lactating, pregnant or plan to become pregnant
• Morbid obesity (BMI >35)
• Age < 21

Potential Side Effects: Potential adverse events associated with laparoscopic surgery and anesthesia include 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 thrombophlebitis (blood clot). Other risks reported after anti-reflux surgery procedures include bloating, nausea, dysphagia (difficulty swallowing), odynophagia (painful swallowing), retching, and vomiting.
Potential risks associated specifically with the LINX Reflux Management System include achalasia (lower part of esophagus does not relax), bleeding, cough, death, decreased appetite, device erosion, device explant/re-operation, device failure, device migration (device does not appear to be at implant site), diarrhea, dyspepsia (indigestion), dysphagia (difficulty swallowing), early satiety (feeling full after eating a small amount of food), esophageal spasms, esophageal stricture, flatulence, food impaction, globus sensation (sensation of a lump in the throat), hiccups, inability to belch or vomit, increased belching, infection, impaired gastric motility, injury to the esophagus, spleen, or stomach, nausea, odynophagia (painful swallowing), organ damage caused by device migration, pain, peritonitis (inflammation of the peritoneum), pneumothorax (collapsed lung), regurgitation, saliva/mucus build-up, stomach bloating, ulcer, vomiting, weight loss, and worsening of preoperative symptoms (including but not limited to dysphagia or heartburn).

*Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates.
** The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and interventional solutions businesses within Johnson & Johnson's Medical Devices segment. 
*** Luigi Bonavina, MD is a paid consultant for Ethicon.

1. Complete cessation of daily dose PPIs observed in 79% of patients at 9-year median follow up (n=124). Ferrari D, Asti E, Lazzari V, et al. Six to 12-year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease. Sci Rep. 2020. 10(13753).
2. Ferrari D, Asti E, Lazzari V, et al. Six to 12-year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease. Sci Rep. 2020;10(1):13753. doi:10.1038/s41598-020-70742-3. 
3. El-Serag HB, Sweet S, Winchester C, et al. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2014. 63(6): 871-80. Poisson regression model of 16 studies yielded a sample size-weighted mean of 19.8% for the prevalence of GERD in the US.
4. Based upon a 6-12 years follow up study of 124 patients. Favorable outcomes were defined as ≥ 50% improvement in GERD-HRQL total score and PPI discontinuation. Ferrari D, Asti E, Lazzari V, et al. Six to 12-year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease. Sci Rep. 2020. 10(13753).
5. https://www.americanforegutsociety.org/wp-content/uploads/2019/10/AFS-LINX-Final.pdf
6. Based on a RCT comparing patients on twice-daily PPI (BID PPI) to  patients treated with laparoscopic MSA who all underwent impedance-pH testing. 91% of MSA patients vs. 58% of BID PPI patients had a normal number of reflux episodes at 6 months (p<0.001).  Bell R, Lipham J, Louie B, et al. Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: A randomized controlled trial. 2018.  Gastrointestinal Endoscopy. 
7. Ayazi S, Zaidi AH, Zheng P, et al. Comparison of surgical payer costs and implication on the healthcare expenses between laparoscopic magnetic sphincter augmentation (MSA) and laparoscopic Nissen fundoplication (LNF) in a large healthcare system https://doi.org/10.1007/s00464-019-07021-4