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FDA Approves Implanted Reflux Disease Treatment Device

Fast food (DigitalVision/NIEHS.gov)

(DigitalVision/NIEHS.gov)

The U.S. Food and Drug Administration approved the Linx Reflux Management System, a surgical implant device for people diagnosed with gastroesophageal reflux disease (GERD). The Linx system is made by Torax Medical Inc. in St. Paul, Minnesota.

GERD is a condition where the stomach contents leak backwards from the stomach into the esophagus, irritating or even damaging the esophagus, and causing heartburn and other symptoms. For most people, a ring of muscle fibers prevents food from moving backward into the esophagus, but if the muscles are not working well, stomach acid can leak back, a process called reflux.

In many cases, dietary and lifestyle changes can the frequency and severity of GERD, and there are medications available to treat the condition. The Linx system is designed for patients with severe or chronic GERD cases, or where medications are ineffective. It consists of a small band of interlinked titanium beads with magnetic cores. The magnetic attraction between the beads can help the muscles at the top of the stomach resist opening to gastric pressures, preventing reflux from the stomach into the esophagus.

FDA cites two clinical studies conducted by Torax to support its approval of the Linx system, where the benefits from the system outweigh its risks. The trials include a study of 100 patients at 14 sites who had chronic GERD symptoms despite medical therapy. The most common adverse events experienced with the Linx system included difficulty swallowing, pain when swallowing food, chest pain, vomiting, and nausea.

The agency notes that patients with the Linx system will no longer be able to undergo Magnetic Resonance Imaging (MRI) scans. 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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