The Food and Drug Administration on Thursday approved LINX Reflux Management System, an implantable device, for treating people with gastroesophageal reflux disease, resistant to anti-reflux drug therapy.
Gastroesophageal Reflux Disease, or GERD, is a chronic, often progressive condition in which food or liquid in the stomach flows back into the esophagus. The most common symptom of GERD is heartburn. It is estimated that nearly 19 million Americans are affected by GERD.
The treatment options for GERD vary depending upon the severity and symptoms of the disease. The three primary means of treating GERD include, lifestyle changes, medical therapy and surgical intervention.
Some of the common medications used to treat GERD are, H2 blockers like, Tagamet, Zantac and Pepcid, antacids like, Maalox, Mylanta, Tums, Alka-Seltzer and Rolaids, and proton pump inhibitors like, Nexium, Prevacid and Protonix. For people with severe GERD symptoms, surgical treatment is the only option.
LINX Reflux Management System, developed by privately held US-based medical device company Torax Medical Inc., serves as an alternative to current surgical procedures.
The LINX System is a small flexible band of interlinked titanium beads with magnetic cores. The device is placed around the esophagus just above the stomach using a common, minimally invasive surgical technique called laparoscopy, to augment the weak Lower Esophageal Sphincter and restore the body's natural barrier to reflux.
Difficulty swallowing, pain when swallowing food, chest pain, vomiting and nausea are some of the the most common adverse events associated with the LINX system.
The FDA in a statement said that patients with LINX will no longer be able to undergo Magnetic Resonance Imaging 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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