AUGUST 19, 2024

FDA Expands Indication to BE for Magnetic Sphincter Augmentation Device

The FDA has expanded the indication for the magnetic sphincter augmentation device LINX (Ethicon/Johnson & Johnson MedTech) to encompass patients with Barrett’s esophagus who are experiencing gastroesophageal reflux disease.

Previously, the device was only indicated for patients with GERD. The expanded indication, for patients with BE and GERD (not BE alone), follows positive data that found nearly 61% of patients had regression in their BE after device implantation (Surg Endosc