March 23, 2012
On March 22, 2012, the FDA approved the LINXTM Reflux Management System, a single-use, surgically placed device, used to treat chronic symptoms in people with gastroesophageal reflux disease (GERD) who have not responded to other treatments. GERD is a condition in which stomach contents flow backwards into the esophagus, causing irritation of the esophagus, heartburn, and other symptoms. Many patients with GERD are advised to make dietary changes, such as avoiding types of food that may trigger symptoms, or are advised to take certain medications, such as antacids or proton pump inhibitors; surgery is often reserved for patients who have severe symptoms or a large hiatal hernia. Now, patients with GERD have another option. The LINX system is composed of titanium beads, each with a magnetic core, strung together to form a ring shape that is implanted at the lower esophageal sphincter (LES), the muscle that closes the esophagus and prevents backward flow of liquid and food in the stomach. According to the FDA, the ring is designed to strengthen a weak LES; while eating, the device is forced to expand due to the higher pressures of swallowing, but then returns to its resting state once food has passed through it.
The LINX system was approved after a feasibility study of 44 patients and a pivotal study of 100 patients. Both studies had a 5-year follow-up period and involved patients with chronic GERD symptoms despite using other medical therapies. The study results showed that benefits obtained with LINX outweighed the risks; the most common adverse events reported with LINX were difficulty swallowing, pain when swallowing food, chest pain, vomiting, and nausea. Additionally, patients with LINX can no longer undergo magnetic resonance imaging, as the magnetic beads interfere with the machine, cause damage to the device, and injure the patient. As a condition of approval, the manufacturer, Torax Medical Inc, will institute an educational program for new users on patient selection, device implantation, a post-procedural care. Learn more about the LINX reflux surgery at http://linxrefluxsurgery.com.