Gastroesophageal Reflux Disease
Gastroesophageal reflux disease, also referred to as GERD, is a condition in which stomach acids back up into the esophagus. Normally, a ring of muscle at the lower end of the esophagus, called the esophageal sphincter (LES), prevents the backflow of partially digested food and stomach acid into the esophagus. When the LES doesn’t close properly or opens spontaneously (from excess pressure in the stomach), the stomach contents can flow back into the esophagus, causing acid reflux, or acid regurgitation.

According to the American College of Gastroenterology, about 15 million Americans have daily heartburn symptoms and 60 million experience the problem at least once a month. When reflux is persistent and occurs more than twice a week, patients are considered to have GERD.

Treating GERD
Mild symptoms of GERD can often be treated with lifestyle changes and medications. Patients are generally advised to stop smoking, lose weight, avoid foods that trigger acid reflux, eat frequent smaller meals, wear loose-fitting clothing, avoid lying down for 3 hours after eating and raise the head of their bed. Over-the-counter antacids and heartburn medications may also be helpful. If symptoms are more significant or occur regularly, prescription medications may be recommended.

When lifestyle changes and medications fail to ease symptoms, doctors may recommend surgery. In one procedure, called Nissen fundoplication, the upper part of the stomach is brought up and wrapped around the LES to provide support and strength to the muscle, preventing the back flow of acid. Other procedures create tiny folds, or pleats, in the LES to tighten the muscle. Another treatment makes tiny, intentional burns on the LES to create scar tissue, which is tougher than muscle and less likely to stretch under stomach pressure.

The LINX™ Reflux Management System
Another system under study for treatment of GERD is called the LINX™ Reflux Management System. LINX is a string of tiny magnetic beads encased in titanium. During laparoscopic surgery, the beads are placed on the lower end of the esophagus, forming a ring around the LES. The force of the magnets pulls each bead closer to those on each side, like a stretchy bracelet. Patients are able to stop their medications and eat a normal diet by the time they go home on the day after the surgery.

Jeffrey Peters, M.D., Esophageal Surgeon with the University of Rochester Medical Center, says the magnets provide extra support for a weak LES. Once in place, the magnetic ring stretches open to allow food and liquids to pass into the stomach during a swallow. After the food passes through, the ring tightens again.

Currently, the LINX system is in clinical trials. Peters says there are some potential risks with the system. It’s possible that the beads will migrate from their intended location and need to be removed or replaced. If the magnetic ring is wrapped too loosely around the LES, it will not effectively work. On the other hand, if the ring is too tight, food will be unable to pass into the stomach.

The current trial is taking place in 16 cities across the U.S. (a list follows). However, the researchers are no longer accepting new participants. Peters says, even if the system is eventually approved, the treatment would most likely not be recommended for patients with severe GERD or Barrett’s esophagus.

LINX™ Clinical Trial Locations:

Los Angeles, CA
San Diego, CA
Jacksonville, FL
Albany, GA
Minneapolis, MN
Rochester, MN
St. Louis, MO
Rochester, NY
Columbus, OH
Mount Vernon, OH
Portland, OR
Philadelphia, PA
Pittsburgh, PA
Nashville, TN
Seattle, WA
LaCrosse, WI



AUDIENCE INQUIRY
For information about the LINX™ Reflux Management System, go to http://www.toraxmedical.com/patients/linx.php. Information about the study can be found at http://www.refluxstudy.com.

For information on GERD:
American College of Gastroenterology, http://www.acg.gi.org
National Institute of Diabetes and Digestive and Kidney Diseases, http://www.niddk.nih.gov

BIBLIOGRAPHY
Flook, Nigel, M.D., et al., “Approach to Gastroesophageal Reflux Disease in Primary Care,” Canadian Family Physician, May 2008, Vol. 54, No. 5, pp. 701-705.

Gisbert, Javier, et al., “Impact of Gastroesophageal Reflux Disease on Patients’ Daily Lives,” Health and Quality of Life Outcomes, July 2, 2009, Vol. 7, No. 60.

Grant, Adrian, et al., “Minimal Access Surgery Compared with Medical Management for Chronic Gastro-Oesophageal Reflux Disease,” British Medical Journal, December 15, 2008, Vol. 337, p. a2664.

Jozkow, Parvel, et al., “The Relationship Between Gastroesophageal Reflux Disease and the Level of Physical Activity,” Swiss Medical Weekly, August 25, 2007, Vol. 137, No. 33-34, pp. 465-470.

Rantanen, Tuomo, M.D., Ph.D., et al., “Complications in Antireflux Surgery,” Archives of Surgery, April 2008, Vol. 143, No. 4, pp. 359-365.