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New Device Approval

Note: Physicians should stop injecting ENTERYX® immediately and follow the manufacturer’s procedures for returning unused product.

Physicians are advised to immediately stop using ENTERYX®.

Please see the Public Health Notification

Enteryx™ Procedure Kit - P020006

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Enteryx™ Procedure Kit
Manufacturer: Enteric Medical Technologies, Inc.
Address: 551 Foster City Blvd., Suite G, Foster City, CA 94404
Approval Date: April 22, 2003
Approval Letter: http://www.fda.gov/cdrh/pdf2/p020006a.pdf

What is it? Enteryx™ is a permanently implanted device used 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 throat. The device is a solution made up of a polymer and a solvent that is implanted by injection into the wall of the lower esophagus. An injection catheter, syringes, and needles are also contained within the device kit.

How does it work? The device is intended to help in keeping stomach acid from backing up into the lower esophagus by strengthening the muscle that separates the lower esophagus from the stomach. During an endoscopic procedure done under special x-ray guidance, the solution is injected by way of a needle catheter into the lower esophagus. After the injection, the solvent separates away, leaving the polymer to solidify into a spongy material that is intended to help prevent the reflux.

When is it used? The device is used in patients who have symptoms of gastroesophageal reflux disease who require certain medications.

What will it accomplish? The device may help eliminate or reduce the need for medications and improve the symptoms of GERD. In a 12-month study of 85 patients conducted within the United States, Canada, and Europe, approximately 67% of the subjects were able to discontinue all of their medications. An additional 9% were able to reduce their required dose by at least one-half. Most patients (72%) noted an improvement in their symptom score assessment of at least 50% when compared to taking no medications prior to implant. Although many patients experienced improvement in their symptoms and medication requirements, evaluations of the esophagus performed during the clinical trial showed evidence of persistent acid reflux in more than half (61%) of the patients and low-grade inflammation in the lower esophagus in 37% of patients at 12 months.

What are the risks? The most common side effect was pain beneath the breastbone that occurred in more than 90% of the patients but usually got better within 2 weeks. Other common side effects included temporary difficulty with swallowing (dysphagia) in 20%, fever in 12%, sore throat in 11%, and gas/bloating/belching in 7% of the subjects.

When should it not be used? The device should not be used in people who:

• are not able to undergo an endoscopic procedure or
• have dilated veins in the esophagus (esophageal varices) due to liver disease

Additional information: The SSED and Labeling will be available at:
http://www.fda.gov/cdrh/pdf2/p020006.html

Updated 6/10/2003

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