FDA approves LINX Reflux Management System
The FDA has approved the LINX Reflux Management System for people diagnosed with gastroesophageal reflux disease (GERD) and who continue to have chronic symptoms despite the use of maximum medical therapy for the treatment of reflux.
GERD, a condition in which food or liquid in the stomach flows back into the esophagus, causes heartburn and other symptoms. The LINX Reflux Management System is a sterile, single-use, surgically placed device used to treat the symptoms associated with GERD. It will serve as an alternative to current surgical procedures or antacid inhibitors.
The LINX system, manufactured by St. Paul, Minn.-based Torax Medical, 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.
Torax 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. Results from both the feasibility and pivotal trials indicate that the benefits obtained with the LINX Reflux Management System outweigh its risks. The most common adverse events experienced with the LINX included difficulty swallowing, pain when swallowing food, chest pain, vomiting, and nausea.
It is important to note that patients with LINX will no longer be able to undergo MRI procedures, as the magnetic beads interfere with the machine and can cause the device to be damaged and the patient to be injured.