Image: The LINX Gastroesophageal Reflux Management System (Photo courtesy of Torax Medical).

An innovative bracelet composed of a series of miniature magnetic beads aids treatment of medically resistant gastroesophageal reflux disease (GERD).

The LINX Gastroesophageal Reflux Management 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 by laparoscopy around the lower esophageal sphincter (LES). The force of the magnetic beads is designed to provide additional strength to keep a weak LES closed, preventing the backward flow of stomach contents. 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.

A feasibility study involving 44 patients at four centers, as well as a pivotal study of 100 patients at 14 centers--both with five-year follow-up plans--indicate that the benefits of using the system outweigh the risks. Aside from possible side effects such as difficulty and pain when swallowing food, one important disadvantage of the system is that patients with the device implanted will no longer be able to undergo Magnetic Resonance Imaging (MRI) procedures. The LINX Gastroesophageal Reflux Management System is a product of Torax Medical (St. Paul, MN, USA), and has received the European Community CE marking of approval.

“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 at the US Food and Drug Administration (FDA) Center for Devices and Radiological Health, which has unanimously recommended FDA approval of the device. “LINX offers an option to patients and their health care providers and is an alternative to current surgical procedures.”

GERD is a chronic symptom of mucosal damage caused by stomach acid refluxing from the stomach into the esophagus; typical symptoms include heartburn, regurgitation, and trouble swallowing. It is usually caused by changes in the barrier between the stomach and the esophagus, including abnormal relaxation of the LES, impaired expulsion of gastric reflux from the esophagus, or a hiatal hernia.

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