WEDNESDAY, April 23, 2003 (HealthDayNews) -- A permanently implanted device to prevent the symptoms of gastroesophageal reflux disease (GERD) has been approved by the U.S. Food and Drug Administration.
GERD symptoms -- including heartburn and a burning sensation in the chest or back of the throat -- occur when stomach acid backs up into the esophagus. More than 60 million Americans have the disease and 25 million have daily symptoms. Chronic GERD often requires daily medication.
Enteryx, produced by the Boston Scientific subsidiary Enteric Medical Technologies, comprises a polymer device and a solvent. After implantation, the solvent separates away and the polymer solidifies into a spongy material that binds to the implantation site in the lower esophagus, preventing the fluid backup.
In a 12-month study of 85 people in the United States, Canada, and Europe, the device allowed 67 percent of all participants to stop all of their GERD medications. Another 9 percent said they could reduce their use of the GERD drugs by half.
Enteryx shouldn't be used in people who have dilated veins in the esophagus due to liver disease. Also, it can't be implanted in people who cannot tolerate a procedure involving use of endoscopic equipment in the lower throat.
The most common side effect of the device was pain beneath the breastbone, which usually subsided within two weeks. Others included temporary difficulty swallowing, fever, sore throat, and gas/bloating.
Here is the FDA Talk Paper announcing the approval. For more information about GERD, visit the National Institute of Diabetes and Digestive and Kidney Diseases.
