The new FDA labeling expands Linx’s availability to include patients with Barrett’s esophagus (BE) experiencing gastroesophageal reflux disease (GERD) symptoms. The FDA based its decision on a retrospective review of a 2021 study that found Linx safe and effective in managing GERD symptoms in patients with BE.
Linx, a flexible ring of small magnets, is placed around the lower esophageal sphincter (LES) muscle. It helps prevent acid reflux and proved successful in treating GERD in patients with and without BE. Ethicon acquired Torax and the Linx system for an unspecified amount in March 2017.
The system provides an alternative to medications that control or suppress acid production in the stomach to treat GERD. According to Ethicon, these medications fail to address the mechanical cause of GERD — a weak LES muscle.
Dr. John C. Lipham of Keck Medicine of USC, served as study investigator on the paper that supported the label update. Lipham said Linx demonstrated “remarkable efficacy” in alleviating GERD symptoms in BE patients. Additionally, Lipham says the system can provide “much-needed relief” along with improved quality of life.
“We understand the urgency for patients with Barrett’s esophagus experiencing gastroesophageal reflux disease to find relief from symptoms. “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,” said Jörg Tomaszewski, medical director, bariatric, Johnson & Johnson MedTech.
