Johnson & Johnson MedTech Announces Labeling Amendment of LINX™ Reflux Management System in the U.S. to Include Patients With Barrett’s Esophagus Experiencing Gastroesophageal[...]

CINCINNATI, OH August 7, 2024- Ethicon*, a Johnson & Johnson MedTech company**, announced today that the U.S. Food & Drug Administration (FDA) has approved a label update to expand the availability of the LINX™ Reflux Management System to include patients with Barrett's esophagus (BE) experiencing gastroesophageal reflux disease (GERD) symptoms. The decision is based on a retrospective review of a 2021 study that found LINX™ to be safe and effective in managing GERD symptoms in patients with BE.^1,†

"The LINX™ Reflux Management System demonstrated remarkable efficacy at alleviating symptoms of gastroesophageal reflux disease in patients with Barrett's esophagus," said Dr. John C. Lipham^‡, General Surgery, Gastrointestinal Surgery, Foregut Surgery at Keck Medicine of USC, Study Investigator on the paper supporting this label update. "With the opportunity to extend this treatment option to more patients with GERD, I am thrilled for patients to experience much-needed relief from this condition and experience improved quality of life."

It is estimated that 20 percent of adults in the U.S. suffer from GERD, which is a risk factor for BE, a condition in which tissue similar to the lining of the intestine replaces the lining in the esophagus.^2,3Millions of patients rely on medications that control or suppress acid production in the stomach to treat GERD. However, these medications do not address the mechanical cause of GERD, which is a weak lower esophageal sphincter (LES) muscle. LINX™, a flexible ring of small magnets placed around the LES to help prevent acid reflux, has demonstrated success in treating GERD in patients with and without BE. A single-arm clinical trial (NCT00776997) showed 71 percent of patients with BE who were experiencing GERD symptoms were free from dependence on daily reflux medication after LINX.¹

"We understand the urgency for patients with Barrett's esophagus experiencing gastroesophageal reflux disease to find relief from symptoms," said Jörg Tomaszewski, Medical Director, Bariatric, Johnson & Johnson MedTech. "This decision from the FDA to revise the labeling for LINX™ underscores Johnson & Johnson's unwavering commitment to offering innovative solutions that safely and effectively serve as many patients as possible."

For additional information about the LINX™ Reflux Management System, visithttps://www.jnjmedtech.com/en-US/product/linx-reflux-management-system.

About LINX™ Reflux Management System
The LINX™ Reflux Management System is a laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD). LINX™ is a flexible ring of small magnets placed around the lower esophageal sphincter (LES)-the strength of the magnets is precisely calibrated to help keep the weak LES closed to prevent reflux.

About Ethicon
At Ethicon, a Johnson & Johnson MedTech company, putting humanity at the core of care is our passion and our purpose. In collaboration with clinicians and health care experts around the world, we develop clinically-differentiated surgical technologies and solutions to help address some of the most pressing health challenges of our time such as metabolic disease, cardiovascular disease and cancer. Through our efforts and ingenuity, we aspire to elevate standards of care and create a healthier future for the patients of today and tomorrow. Visitwww.ethicon.comto learn more about us.

About Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized. For more, visithttps://thenext.jnjmedtech.com.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. 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 Ethicon, Inc., Ethicon Endo-Surgery, LLC, Johnson & Johnson Enterprise Innovation Inc., and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; 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 January 1, 2023, 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 atwww.sec.gov,www.jnj.comor on request from Johnson & Johnson. None of Ethicon, Inc., Ethicon Endo-Surgery, LLC, Johnson & Johnson Enterprise Innovation Inc., nor Johnson & Johnson undertake 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. 

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 use of the LINX device has been evaluated and found to be safe and effective for the management of GERD symptoms in patients with Barrett's Esophagus (BE). LINX has not been evaluated as a primary treatment for BE; patients with BE who are treated with LINX for management of GERD symptoms should consult with their physician for continued treatment of BE (including PPI use).

The safety and effectiveness of the LINX device has not been evaluated in patients with 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 with the exception of Laparoscopic Sleeve Gastrectomy (LSG) which has been evaluated for safety and efficacy.
• 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, swallow-induced syncope (fainting), stomach bloating, ulcer, vomiting, weight loss, and worsening of preoperative symptoms (including but not limited to dysphagia or heartburn).

© Johnson & Johnson MedTech, Inc. 2024. All rights reserved.

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*Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates. All other trademarks are the property of their respective owners.

**Johnson & Johnson MedTech comprises the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson's MedTech segment.

^† The use of the LINX device has been evaluated through a systematic literature review. While the data for use of the LINX device for the treatment of GERD related symptoms in patients with BE is limited, the available literature found use of the LINX device to be safe and effective for the management of GERD symptoms in patients with Barrett's Esophagus (BE). The outcomes from a single observational study (Dunn et al.)provide evidence of post operative pH improvement. Surgical treatment of BE patients has not been demonstrated to prevent progression to cancer.

^‡Dr. John C. Lipham is a paid consultant for Ethicon. He has not been compensated for any media work.

Footnotes
¹Dunn CP, Henning JC, Sterris JA, et al. Regression of Barrett's esophagus after magnetic sphincter augmentation: intermediate-term results. Surg Endosc. 2021;35(10):5804-5809

²Antunes C, Aleem A, Curtis SA. Gastroesophageal Reflux Disease. [Updated 2023 Jul 3]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK441938/

³National Institute of Diabetes and Digestive and Kidney Diseases. Barrett's Esophagus. Available at: Barrett's Esophagus - NIDDK (nih.gov)

Media contact:
Carlos Taveras
Communications Leader, Ethicon US
[email protected]

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