Enteryx™ Procedure Kit

Gastroesophageal reflux disease (GERD), more commonly referred to as acid reflux disease, affects 7 to 10 percent of the U.S. adult population. Studies show that acid reflux disease has the second largest negative impact on quality of life. To put this in perspective, mental illness ranks first, stomach ulcers is third and heart pain ranks fourth.

The Enteryx™ solution is a liquid polymer injected into the muscle layer of the lower esophageal sphincter. Once in the muscle, the liquid forms a soft, sponge-like material that supports and improves the elasticity of the lower esophageal sphincter. This prevents or reduces acid reflux from the stomach into the esophagus.

Currently, the Enteryx product is under Pre-Market Approval (PMA) review at the FDA, making it the first less-invasive medical device treatment for acid reflux disease to undergo this stringent evaluation. In January 2003, the Gastroenterology and Urology Devices Panel voted unanimously to recommend to the FDA the approval of the Enteryx product for the treatment of symptoms of acid reflux disease in patients who require and respond to pharmaceutical therapy.