Magnetic Titanium Implant Stopped Heartburn in Clinical Trial

A new kind of implant that consists of a loop of magnetic, titanium beads reestablishes the functionality of the esophageal sphincter and thus relieves chronic heartburn symptoms that standard treatment cannot, a clinical trial shows. The LINX Reflux Management System is a kind of bracelet made of magnetic beads that is implanted around the end of the esophagus, where the lower esophageal sphincter is located, which is the natural valve that prevents reflux; when it weakens, GERD develops.

“These results show that there is another option for the millions of people suffering from chronic reflux,” says John Lipham, associate professor of surgery at the Keck School of Medicine of University of Southern California.

Lipham, who led the successful clinical investigation of the device, said that implantation of the device can be completed in 15 to 20 minutes and will potentially be an outpatient procedure.

Lipham and his colleagues assessed 100 patients with GERD before and after surgery, finding that acid reflux decreased, reflux symptoms improved and the use of medication to manage those symptoms decreased for most patients. Their findings are published in the New England Journal of Medicine.

Severe regurgitation was eliminated in all patients. More than 9 in 10 patients reported satisfaction with their overall condition after having the procedure, compared to 13 percent before treatment while taking medication.

More than 60 million Americans experience heartburn at least once a month, and some studies have suggested that more than 15 million experience heartburn symptoms every day, according to the American College of Gastroenterology.

Lipham says the LINX device is best suited for patients with mild to moderate reflux that cannot be adequately controlled by medication or for patients who do not want to take medication to manage the disease. For those with severe reflux, the currently only and complicated surgical treatment called Nissen fundoplication is recommended, which involves recreating the esophageal sphincter, but prevents the ability to belch or vomit and often leads to bloating or gas problems.

The most common adverse events experienced with the LINX device included difficulty swallowing, pain when swallowing food, chest pain, nausea, and vomiting--follow-up studies are still required to assess long-term safety.

The Keck Medical Center of USC was one of 14 US and European medical centers to test the device prior to its approval last March by the US Food and Drug Administration. The device is manufactured by Minnesota-based Torax Medical Inc.

Study:

Esophageal Sphincter Device for Gastroesophageal Reflux Disease