Torax Medical has received FDA approval for its LINX Reflux Management System for the treatment of gastroesophageal reflux disease (GERD) resistant to medical therapy.
The device, described as a “bracelet” around the Lower Esophageal Sphincter, is composed of a series of miniature magnetic beads, and can be implanted laparoscopically.
From the press release:
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.
Aside from possible side-effects such as difficulty swallowing and pain when swallowing food, one important disadvantage of the LINX is that patients with the device implanted will no longer be able to undergo Magnetic Resonance Imaging (MRI) procedures. The LINX received CE Mark approval two years ago.
Product page: LINX Reflux Management System…