Put a ring on it: New implant device for chronic heartburn

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Those who suffer from chronic, severe gastroesophageal reflux disease (GERD) may soon be able to seek relief via a new implantable device. Called the LINX Reflux Management System, the new device was just unanimously recommended for approval by an FDA advisory committee; they deemed it safe and effective for treating GERD that does not respond to medication.

The LINX device is a titanium ring composed of magnetic beads that, when placed around the lower end of the esophagus, prevents acid stomach contents from spilling back into the esophagus. In the pivotal clinical trial that informed the advisory committee s decision, 100 patients had the device implanted via a minimally invasive surgery. These participants had suffered from GERD for an average of 13 years without satisfactory relief from other treatments, including acid blockers, bed elevation, and dietary changes. Twelve months later, the esophageal acid level in over half the patients had fallen by at least one-half the level measured just before surgery. Furthermore, at 12 and 24 months after the implantation, an even greater number of patients reported a marked improvement in the heartburn symptoms of GERD.

Overall, the FDA advisory committee determined that the benefits of the LINX device outweigh its risks. However, the device is not without caveat. Three-quarters of the trial participants experienced some adverse effects most commonly, difficulty swallowing. About a quarter of the patients experienced pain, while five patients needed to have the device removed altogether. Finally, because LINX is magnetic, patients cannot undergo MRI scans (which use strong magnetic fields). Torax Medical, the manufacturer of the device, will conduct a 200-subject follow-up study to confirm the long-term safety and effectiveness of LINX.

ACSH s Dr. Gilbert Ross believes the new device warrants attention, given that about 19 million adults in the U.S. alone suffer from GERD, a condition that can be debilitating. He observes that, as an option for patients who don t respond to any other methods, the LINX device may be a welcome treatment.