Photo: John Lipham, M.D., associate professor of surgery at the Keck School of Medicine of USC.
A U.S. Food and Drug Administration (
FDA)
advisory panel has endorsed approval of a novel device to treat severe
acid reflux. The device was tested in clinical trials at
USC.
John
Lipham, M.D., 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 U.S.,” 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 is potentially an outpatient procedure that
can be completed in 15 to 20 minutes, Lipham said.
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.
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 LINX 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
and Urology Devices Panel
met on Wednesday, 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.