J&J’s Ethicon Gets FDA OK for LINX Reflux Management Label Expansion

Ethicon, a Johnson & Johnson MedTech company, has received U.S. Food and Drug Administration (FDA) approval for a label expansion of its LINX reflux management system.
 
The labeling update extends LINX’s use to patients with Barrett’s esophagus (BE) who have gastroesophageal reflux disease (GERD) symptoms. This decision was based on a retrospective review of a 2021 study that showed LINX was safe and effective to manage these types of patients.
 
GERD is caused by a weak LES and is typically treated with medications that control or suppress acid production in the stomach. LINX is a flexible ring of small magnets placed around the lower esophageal sphincter (LES) muscle to help prevent acid reflux. The laparoscopic, fundic-sparing anti-reflux LINX procedure uses the strength of the calibrated magnets to keep the weak LES closed.
 
Clinical trial data showed 71% of patients with BE who had GERD symptoms did not have to depend on daily reflux medication after treatment with LINX.
 
“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.”