Clinical trial results published in the New England Journal of Medicine this week offer additional evidence that a new device may help relieve chronic heartburn symptoms that standard treatment cannot. The Keck Medical Center of USC was one of 14 U.S. and European medical centers to test the device prior to its March 2012 approval by the U.S. Food and Drug Administration.
John Lipham, M.D., associate professor of surgery at the Keck School of Medicine of USC, led clinical investigation of the device at USC as part of his ongoing work to find alternative ways to treat gastroesophageal reflux disease (GERD), or chronic heartburn.
"These results show that there is another option for the millions of people suffering from chronic reflux," Lipham said. "Currently, the Keck Medical Center of USC is one of only 30 sites in the country certified to implant the device."
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 is potentially an outpatient procedure that can be completed in 15 to 20 minutes, Lipham said.
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. 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.
Follow-up studies are still required to assess long-term safety.
Lipham says the LINX 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. 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.
Surgical treatment of reflux disease had been limited to a 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 most common adverse events experienced with the LINX included difficulty swallowing, pain when swallowing food, chest pain, vomiting, and nausea. It is important to note that patients with LINX will no longer be able to undergo magnetic resonance imaging (MRI) procedures. The magnetic beads interfere with the machine and can cause the device to be damaged and the patient to be injured.