A novel device, approved by the FDA, will be used by the Mayo Clinic in Florida to treat gastroesophageal reflux disease (GERD), also known as acid reflux disease that can cause serious health problems.
The U.S. Food and Drug Administration (FDA) approved the
device and treatment procedure on March 22 for patients with GERD who continue
to have chronic reflux symptoms despite taking medication.
Mayo Clinic in Florida
expects to offer the new treatment immediately, says C. Daniel Smith, M.D.,
chair of the Surgery Department at Mayo Clinic in Florida, and an internationally recognized
expert on the treatment of GERD.
Dr. Smith is experienced in using the system because Mayo
Clinic in Florida was one of only 14 centers nationally that participated in a
clinical trial that led to the FDA's approval of the device.
"Mayo has been a leader in the treatment of esophageal
diseases, especially GERD, and we are pleased to be offering this new treatment
to our patients immediately," he says.
GERD is a condition in which liquid, or food, in the stomach
flows back up into the esophagus due to the inability of a ring of muscle
between the lower esophagus and the top of the stomach to close properly.
If drugs aimed at neutralizing the acid in the stomach fails
to prevent GERD, an operation designed to correct the mechanical defect is
considered. But between 1.5 million and 2 million patients of those patients
could benefit from treatment that is much less complex than current surgical
options, Dr. Smith says.
"The new system will offer a long-needed treatment option
for a large group of underserved patients," he says.
The results of the clinical study that led to approval of
the device have not yet been published. But "the data presented to the FDA
revealed striking results when compared to other GERD treatments that have been
investigated over the past 20 years," Dr. Smith says. "The system offers
effective control of GERD with limited side effects and thus far an excellent
The implanted device is a ring of tiny magnetic titanium
beads that is wrapped around the junction between the stomach and esophagus,
serving as a mechanical augmentation of the lower esophageal sphincter (the
ring of muscle). The magnetic attraction between the beads is strong enough to
keep the sphincter closed to refluxing acid, but weak enough so that food can
pass through it into the stomach, Dr. Smith says. The device can be implanted
using minimally invasive surgery methods.
Dr. Smith performs about 200 GERD-related surgeries a year
and has been involved with many new treatments over the past several decades.
"I expect this device to be a game changer for the treatment of GERD in select
patients who have failed management with drugs," says Dr. Smith.
Ken DeVault, M.D., chair of the Department of Internal
Medicine at Mayo Clinic in Florida,
also participated in these studies. "I have many patients who are searching for
something more than medication for their reflux, but have been hesitant to
undergo a traditional reflux surgery," he says. "I think this procedure may
well be a very attractive option for that group."
Mayo Clinic physicians and scientists collaborated with
Torax Medical in the development of the LINX Reflux Management System, and Mayo
Clinic licensed related technology to the company in exchange for equity. Drs.
DeVault and Smith are paid consultants to Torax Medical.