The Food and Drug Administration today approved the LINX Reflux Management System for people diagnosed with GERD who continue to have chronic symptoms, despite the use of maximum medical therapy for the treatment of reflux.
"The LINX Reflux Management System is a sterile, single-use, surgically placed device used to treat the symptoms associated with GERD," said Christy Foreman, director of the Office of Device Evaluation in FDA's Center for Devices and Radiological Health. "LINX offers an option to patients and their health care providers and is an alternative to current surgical procedures."
The LINX system is composed of a series of titanium beads, each with a magnetic core, connected together with independent titanium wires to form a ring shape. It is implanted at the lower esophageal sphincter (LES), a circular band of muscle that closes the last few centimeters of the esophagus and prevents the backward flow of stomach contents.
The force of the magnetic beads is designed to provide additional strength to keep a weak LES closed. Upon swallowing, the magnetic force between the beads is overcome by the higher pressures of swallowing forces, and the device expands to accommodate a normal swallow of food or liquid. Once the food passes though the LES, the device returns to its resting state.
The company conducted a feasibility study of 44 patients at four centers with a five-year follow-up plan. In addition, the company conducted a pivotal study of 100 patients at 14 centers with a five-year follow-up plan. Patients enrolled had GERD and chronic GERD symptoms, despite medical therapy. It is reported that the results from both the feasibility and pivotal trials indicate that the benefits obtained with the LINX Reflux Management System outweigh its risks.
There are reported side effects, with the most common adverse effects included difficulty swallowing, pain when swallowing food, chest pain, vomiting, and nausea.
Patients with LINX will no longer be able to undergo Magnetic Resonance Imaging (MRI) procedures. The magnetic beads interfere with the machine and can cause the device to be damaged and the patient to be injured.
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