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FDA approves new device: LINX Reflux Management System

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Last week, the Food and Drug Administration (FDA) approved a new medical device geared toward chronic gastroesophageal reflux disease (GERD) sufferers. GERD causes heartburn, regurgitation, sore throat, cough, and chest pain that can result in esophageal cancer if left untreated.

Torax Medical’s LINX Reflux Management System is only intended for those who’ve eaten smaller meals, avoided spicy foods, alcohol, and chocolate, and made other lifestyle changes but failed to respond to antacids like Tums, histamine blockers like Tagamet, and proton pump inhibitors like Nexium.

GERD sufferers have a weak Lower Esophageal Sphincter (LES).weak lower esophageal sphincter, the muscle at the junction of the esophagus and stomach that acts as a valve, allowing food and liquid to pass through to the stomach. Normally, the LES closes after swallowing to prevent reflux. Conversely, a weak LES allows bile and acid to travel from the stomach to the esophagus.

The LINX system is a string of titanium beads with a magnetic core woven into a ring shape that is wrapped around the esophagus just above the stomach via laproscopy. “The magnetic attraction between the beads is designed to close the LES immediately after swallowing, restoring the body’s natural barrier to reflux,” says Torax’s website.

British weight loss surgery provider Healthier Weight assures patients that they will still be able to belch and vomit. In fact, expected side effects include vomiting, nausea, difficulty swallowing, painful swallowing, and chest pain. The FDA recommends that only those patients with chronic GERD or a large hiatal hernia undergo LINX surgery.

The FDA also advises that patients will no longer be able to undergo Magnetic Resonance Imaging (MRI) procedures once implanted with the LINX system. The magnetic beads interfere with the machine and can cause the device to be damaged and the patient to be injured.

As a condition of approval, the St. Paul, MN, company is required to institute a training program to educate new users on patient selection, device implantation and post-procedural care of patients.

Learn more information about the device approvals by visiting the FDA’s website.