Johnson & Johnson Announces FDA Approval of Its Gastric Reflux Treatment Product---LINXNew indications, can be used for treatmentPatients with Barrett's Esophagus (BE) who experience symptoms of Gastroesophageal Reflux Disease (GERD). The FDA approved this indication based on a retrospective review of a 2021 study, which found that LINX is effective in managingPatients with Barrett's Esophagus (BE)is safe and effective in terms of GERD symptoms.
"LINX has demonstrated significant efficacy in alleviating gastroesophageal reflux disease symptoms in patients with Barrett's esophagus. I am pleased to have the opportunity to extend this treatment option to more GERD patients, allowing them to achieve much-needed relief from this condition and experience an improved quality of life."---John C.Lipham Keck Medicine of USC"We understand the urgent need for symptom relief among Barrett's esophagus patients with gastroesophageal reflux disease. The FDA's decision to expand the indication for LINX underscores Johnson & Johnson's unwavering commitment to providing innovative solutions that safely and effectively serve as many patients as possible."---Jörg Tomaszewski, Director of Bariatric Medicine at Johnson & Johnson Medical TechnologiesGastroesophageal reflux disease (GERD) is a common clinical condition, where stomach acid and food flow back into the esophagus, mouth, and throat, causing symptoms such as acid reflux, heartburn, and pharyngitis. Currently, the global population reporting heartburn or reflux symptoms with a frequency of at least once per week is approximately 13.3%, indicating that more than 1 billion people worldwide suffer from varying degrees of GERD.Because gastroesophageal reflux can cause digestive tract symptoms such as acid reflux, regurgitation, heartburn, belching, and abdominal distension, significantly reducing the patient's quality of life (some patients feel that life is not worth living). If gastroesophageal reflux is not treated in time, it may lead to esophageal ulcers, esophageal stricture, Barrett's esophagus, and even induce esophageal cancer, seriously endangering the patient’s life and health.At present, the main treatment for gastric reflux is medication, which can only control or suppress stomach acid, but cannotTo address the mechanical cause of GERD, namely the weakness of the lower esophageal sphincter (LES) muscle. It can be said that this treats the symptoms but not the root cause, so surgical treatment has become an effective option currently available.Lower Esophageal Sphincter (LES) muscle weakness issues, ultimately resolvingGERD。Traditionally likeThe surgical procedure of fundoplication is too traumatic for patients and has too many postoperative complications. Only when there is no alternative will patients opt for this surgery. The majority of patients hope to be treated with medication.
Therefore, innovative technology is needed for the treatment of gastroesophageal reflux. Johnson & Johnson acquired in 2017.LINX, introducing this innovative technology to global gastroesophageal reflux. Initially approved by the FDALINXFor patients with gastroesophageal reflux disease without Barrett's esophagus, Johnson & Johnson subsequently validated the safety and efficacy of LINX through extensive clinical studies. Compared with traditional surgery, it is not only more effective but also safer. Subsequently, Johnson & Johnson initiated a study targeting...Non-Gastroesophageal Reflux in Barrett's EsophagusFlow Patient Study, The Study Shows71% of BE patients with GERD symptoms no longer rely on daily reflux medication after receiving LINX treatment. Excellent clinical outcomes also led to the FDA's expanded...LINXIndications Key.
LINXIt is a magnetic bead for treating gastric reflux through minimally invasive surgery. It is placed during the minimally invasive procedure.Lower Esophageal SphincterThe surrounding flexible small magnet ring does not require changes to the stomach's anatomical structure. The magnetic force of the magnetic beads is designed to help.Lower Esophageal SphincterClosed to prevent gastric reflux. When swallowing LINXCan be temporarily opened to allow food and liquids to pass through.
LINXComposed of a titanium shell, titanium wire, and permanent magnet core, the patient undergoes implantation.LINXVarious imaging examinations can still be performed, such as X-rays, ultrasound, PET, CT, and MRI (up to 1.5T), etc.
Characteristics of LINX Technology
- Permanent magnetic cores provide permanent mutual attraction, allowing the product to be used for a long time.
- The product's unique Roman arch design ensures it does not damage surrounding tissues.
- Using inert metal titanium for medical implants to cover the magnetic core and as titanium wire for connections.
- Adopting a unique fastening device, it will not come off under the action of magnetism.
- The use of bent titanium wire structure provides better roundness when expanded.
EthiconAs part of Johnson & Johnson Medical Devices Companies, Ethicon has made significant contributions to surgery for over 100 years, from creating the first sutures to revolutionizing surgery with minimally invasive procedures.EthiconCommitted to shaping the future of surgery, our dedication is built upon our promise to help address some of the world’s most pressing healthcare challenges, improving and saving more lives. Through Ethicon’s surgical technologies and solutions—including sutures, staplers, energy devices, trocars, and more—along with our commitment to treating serious conditions like obesity on a global scale, we deliver innovations that transform lives.
