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The FDA Approves Implant for Gastroesophageal Reflux Disease

ROCKVILLE, MD -- April 23, 2003 -- The Food and Drug Administration approved Enteryx, a permanently implanted device to help patients with symptoms of gastroesophageal reflux disease (GERD), a condition in which some of the stomach's contents -- including acid -- flows up into the esophagus, causing heartburn and/or burning pain in the chest or back of the throat. More than 60 million American adults experience GERD, and about 25 million of them have daily symptoms.

Inserted through an endoscope procedure, this device prevents the reflux of stomach acid into the throat, potentially allowing patients with chronic GERD to avoid daily medications.

Mild heartburn can be treated by adopting dietary changes such as avoiding foods that cause heartburn and eating smaller portions. Treatment of chronic GERD, however, may also require prescription drugs to help maintain a reduced level of acid secretion in the stomach.

Enteryx, a product of Enteric Medical Technologies, which is a wholly-owned subsidiary of Boston Scientific, Inc., is approved for use in patients who have GERD symptoms and who require and respond to certain medications. The device is a solution made up of a polymer and a solvent which is implanted by injection during an x-ray guided endoscopic procedure into the wall of the lower esophagus. After the injection, the solvent separates away and the polymer solidifies into a spongy material that is intended to help prevent the reflux.

The device has been found to help eliminate or reduce the need for medications, and to improve the symptoms of GERD. In a 12-month study of 85 patients conducted in the United States, Canada and Europe, approximately 67% of the participants were able to discontinue all of their medications, 9% could reduce the dose by at least one-half, and most patients (72%) noted an improvement in their symptoms when compared to taking no medications prior to implant.

Although many patients had improvements in their symptoms and medication requirements, objective evaluations of the esophagus performed during the clinical trial showed evidence of persistent acid reflux in 61% of patients and low-grade inflammation in 37% of patients at 12 months.

The most common side effect observed in patients undergoing Enteryx treatment was pain beneath the breastbone that usually diminished within 2 weeks. Other common side effects included temporary difficulty with swallowing(20% of participants), fever (12%), sore throat (11%), and gas/bloating/belching (7%).

The device should not be used in people who are unable to undergo endoscopy, or who have dilated veins in the esophagus due to liver disease.

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