This article is more than 5 years old. Information may no longer be current.
FDA approves GERD management system
Click Here to Manage Email Alerts
The FDA has issued final approval of an implantable device for patients with treatment-resistant gastroesophageal reflux disease.
The LINX Reflux Management System (Torax Medical) is a ring of magnetized titanium beads connected with titanium wire, designed for use in patients with chronic GERD who have been unresponsive to medical therapy. Upon surgical implantation into the lower esophageal sphincter, the device’s magnetic force helps to close this muscle, and the ring also expands with swallowing to allow normal food and liquid consumption.
“LINX offers an option to patients and their health care providers and is an alternative to current surgical procedures,” Christy Foreman, director of the Office of Device Evaluation at the FDA Center for Devices and Radiological Health, said in a press release. Common side effects of LINX usage have included difficult or painful swallowing, chest pain, nausea and vomiting.
The manufacturer is required to develop a training program for new users to instruct them on patient selection, device implantation and post-procedural care as a condition of the approval.