FDA panel recommends approval of device used at USC to treat heartburn

John Lipham holds an experimental device used to treat reflux disease.

A U.S. Food and Drug Administration (FDA) advisory panel has endorsed approval of a novel device – tested in clinical trials at USC – to treat severe acid reflux.

John Lipham, associate professor of surgery at the Keck School of Medicine of USC, led clinical investigation of the device as part of his ongoing work to find alternative ways to treat gastroesophageal reflux disease (GERD), also known as heartburn. USC was one of 15 sites across the country – one of only two in California – to study the device.

“This device is a huge advance for the treatment of reflux, which affects millions of people in the United States,” Lipham said. “In fact, I have a list of patients waiting for it to be implanted.”

The LINX Reflux Management System, manufactured by Minnesota-based Torax Medical Inc., is like a bracelet made up of magnetic, titanium beads implanted around the end of the esophagus, where the lower esophageal sphincter is located. The lower esophageal sphincter is the valve that prevents reflux, and GERD develops when this valve is weakened.

Implantation of the device potentially is an outpatient procedure that can be completed in 15 to 20 minutes, Lipham said. The device is best 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, he added.

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

Traditionally, reflux disease is treated using a surgical procedure called a Nissen fundoplication, which involves recreating the esophageal sphincter. While fundoplication is recommended for those with severe reflux, it is a complicated procedure that prevents the ability to belch or vomit and often leads to bloating or gas problems.

The new device, which has been available in Europe for about two years, is designed to augment the patient’s native sphincter and return it to a competent valve. The magnetic beads open with pressure, allowing patients to belch, vomit and swallow normally. By allowing patients to belch normally, the device allows air to escape from the stomach, preventing the gas and bloating issues.

Lipham said his patients have had no major complications with the device, though some have reported difficulty swallowing that dissipates after the first month.

The FDA’s Gastroenterology-Urology Devices Panel met on Jan. 11 and voted 9-0 on three counts to endorse approval of the device, affirming its safety, effectiveness and risk-to-benefit ratio. The FDA will review the panel’s recommendation to make its final decision.

After FDA approval, insurance companies will have to determine whether they will cover the cost of the device, which has not yet been determined.