Natick, MA (April 22, 2003) -- Boston Scientific Corporation (NYSE: BSX) announced today it has received approval from the U.S. Food and Drug Administration (FDA) to market the Enteryx® technology for the treatment of symptoms of gastroesophageal reflux disease (GERD) in patients responding to and requiring daily pharmacological therapy with proton pump inhibitors (PPI).GERD afflicts approximately 15 million adults in the U.S. alone, and up to 10 percent of people on a Western diet worldwide. In 2000, $8.3 billion was spent in the U.S. on prescription drugs that treat heartburn, the primary symptom of GERD. While drug therapy remains a viable option for most GERD sufferers, the Company believes that between 10 and 15 percent of the market may be served by endoscopic therapies such as the Enteryx procedure.
The Enteryx procedure involves injecting a patented liquid polymer into the lower esophageal sphincter (LES) that solidifies into sponge-like permanent implant. The implant helps to prevent or reduce reflux of gastric acid into the esophagus. The procedure employs existing endoscopic techniques and is performed under conscious sedation by therapeutic endoscopists on an outpatient basis. Unlike daily drug therapy that treats only the symptoms of GERD, the Enteryx procedure is designed to provide relief by changing the compliance of the gastroesophageal junction, thus addressing the underlying mechanical cause of the disease - LES dysfunction.
"Enteryx is an attractive alternative for both physicians and patients. The procedure builds on current GI physician skills and has produced significant improvement in patients." said Glen Lehman, M.D., Indiana University, Professor of Medicine and Radiology. "After one year, clinical trial patients showed statistically significant improvements in their GERD symptoms: 80 percent showed a significant reduction in drug dependency, with 70 percent completely off their antisecretory medications. Moreover, many patients were able to enjoy foods and beverages that had previously triggered symptoms."
"With the Enteryx procedure, physicians can offer their patients a treatment that has been shown to reduce drug dependency and improve quality of life," said Michael Phalen, President of the Endoscopy business of Boston Scientific. "We look forward to providing therapeutic endoscopists with training and information on the procedure so that they can offer their patients an additional choice in treating their gastroesophageal reflux disease."
The Enteryx procedure kit is currently available for sale in Europe.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices. The Company's products are used in a broad range of interventional medical specialties.
This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with the commercialization of new technologies, competitive offerings, intellectual property and other factors described in the Company's filings with the Securities and Exchange Commission.
