The FDA has approved a label update to expand the availability of Ethicon’s Linx Reflux Management System to include patients with Barrett’s esophagus 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 Barrett’s.
The Linx Reflux Management System is a laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with GERD. The device 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.
“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 the University of Southern California and a study investigator on the paper supporting the 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 US 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. Millions 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 LES muscle. Linx is 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 (Dunn CP et al. Regression of Barrett’s esophagus after magnetic sphincter augmentation: intermediate-term results. Surg Endosc. 2021;35(10):5804-5809).
“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 labelling for Linx underscores Johnson & Johnson’s unwavering commitment to offering innovative solutions that safely and effectively serve as many patients as possible.”
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