Boston Scientific Announces Three-Month Efficacy Data from Randomized Controlled Trial for Enteryx® Procedure
and Orlando, FL (November 2, 2004)-- Boston Scientific Corporation (NYSE: BSX) today announced results supporting the efficacy of the Enteryx Procedure in relieving the symptoms of gastroesophageal reflux disease (GERD) three months after treatment. The multi-center, placebo-controlled clinical trial assigned 32 patients randomly to undergo the Enteryx Procedure and assigned 32 patients randomly to the control group. The primary endpoint of the study was proton pump inhibitor (PPI) usage among patients undergoing the Enteryx Procedure compared with patients who underwent endoscopic treatment but did not receive the Enteryx Procedure. Jacques Deviere, M.D., Hôpital Erasme, Universite Libre de Bruxelles, Brussels, Belgium, and the study's Principal Investigator, presented study findings showing that at three months 68 percent of patients in the Enteryx Procedure group eliminated their daily use of PPIs compared with 41 percent of patients in the control group (p < 0.05).

The Company made the announcement at the 69th annual Meeting of the American College of Gastroenterology, which focuses on the latest scientific advances in gastrointestinal research, treatment of digestive diseases and clinical practice management.

"The data from this study provides preliminary evidence that the effectiveness of the Enteryx Procedure observed in previously reported unblinded, prospective clinical trials reflects actual improvement in symptom relief and is not a placebo effect," said Dr. Deviere. "This data indicates that the Enteryx Procedure could provide GERD patients with an effective approach to addressing the symptoms of their disease."

"We are encouraged by the data from the Enteryx trial," said Michael Phalen, President of the Endoscopy business at Boston Scientific. "The Enteryx Procedure has the potential to provide effective disease management for many patients who struggle daily with the symptoms of GERD."

In April 2003, the U.S. Food and Drug Administration approved the Enteryx Procedure kit for the treatment of symptoms of GERD in patients responding to and requiring daily pharmacological therapy with PPI medications.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit:

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 clinical trials, the regulatory approval process, commercialization of new technologies, third party intellectual property and other factors described in the Company's filings with the Securities and Exchange Commission.