Gastroesophageal reflux disease (GERD) inflicts misery on nearly 20 percent of the U.S. population. Most people have experienced the occasional discomfort of what commonly is known as heartburn, but millions live with it daily, suffering damage to the esophagus that in some cases leads to cancer.
On April 9, Rodd Foster, 60, and James “Shane” Barmby, 58, patients at the Keck Medical Center of USC, were among the first in the nation to have the LINX Reflux Management System implanted since the U.S. Food and Drug Administration (FDA) approved its use on March 22. The device, a bracelet of magnetic, titanium beads that goes around the lower end of the esophagus, was tested in clinical trials at the Keck Medical Center, one of only three centers in California authorized to use it.
“I’ve had GERD for the last 30 years, but it’s gotten worse over the last five,” said Foster, a plumbing contractor from Canyon Country. “I sleep sitting on a couch because I can’t lie down after meals. I can’t eat after 3 p.m. It’s aggravating – I can’t even sit down with my family for dinner. I’m just looking forward to living a normal life.”
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 the disease.
“This device is a huge advance for the treatment of reflux, which affects millions of people in the U.S.,” Lipham said. “It addresses a gap of patients who suffer from GERD but no longer respond well to medication treatment.”
Implantation of the LINX system, manufactured by Minnesota-based Torax Medical Inc., is a procedure that can be completed in 15 to 20 minutes, Lipham said.
As a condition of FDA approval, Torax Medical must institute a training program to educate new users on patient selection, device implantation and postprocedural care of patients treated with the device. In addition to USC, Stanford University and the University of California, San Diego, also are approved to implant the device.
Lipham, who has worked with the device since its inception, said the LINX system 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. Foster and Barmby, who were taking a cocktail of antacids to little avail, were good candidates for the procedure.
“When Dr. Lipham told me I had acid reflux and was the perfect candidate for this device, I started crying,” said Barmby, an actor and country musician who had been sick for years but continuously misdiagnosed. “For the last three years, I haven’t played the guitar. If Dr. Lipham can fix me, I’ll be able to play again.”
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 LINX device, which has been available in Europe for about two years, is designed to augment the patient’s native esophageal 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, which dissipated after the first month. Other common adverse symptoms experienced with the device included pain when swallowing food and chest pain.
It is important to note that patients with LINX no longer will be able to undergo magnetic resonance imaging procedures because the magnetic beads interfere with the machine and can cause the device to be damaged.