Boston Scientific Announces 24-Month Safety and Efficacy Data for Enteryx
and New Orleans, LA (May 18, 2004) -- Boston Scientific Corporation (NYSE: BSX) today announced clinical trial data supporting the safety and effectiveness of the Enteryx procedure in relieving the symptoms of gastroesophageal reflux disease (GERD) at 24 months post-treatment. David A. Johnson, M.D., Professor of Medicine, Chief of Gastroenterology at Eastern Virginia School of Medicine and the study's Principal Investigator, presented study findings Monday showing that 67 percent (43/64) of the patients who were dependent on proton pump inhibitors (PPIs) prior to the Enteryx procedure were no longer using these medications two years after the procedure. An additional five percent (3/64) of the patients were able to reduce their dose of PPIs by at least 50 percent.

The Company made the announcement at the annual Digestive Disease Week (DDW) conference, the largest international gathering of physicians, researchers, and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal (GI) surgery.

At 24 months post-treatment, study results of 64 patients demonstrated that:

  • Enteryx eliminated the requirement for PPI medication in 67 percent of patients, with minimal decline in the beneficial effect from the 12-month time period, when the PPI requirement was eliminated in 73 percent of patients;
  • The number of patients able to reduce PPI use by at least 50 percent was also stable at the 12-and 24-month time periods (84 percent and 72 percent, respectively); and
  • The safety profile for Enteryx was consistent at two years compared to shorter post-treatment times.
  • "Data in this study suggests that GERD symptoms can be managed effectively and safely over a two-year period using the Enteryx procedure," said Dr. Johnson. "These results support the use of Enteryx as an attractive alternative to daily medications for the relief of GERD symptoms."

    "The data continues to validate Enteryx as an attractive alternative for relief of GERD symptoms," said Michael Phalen, President of the Endoscopy business at Boston Scientific. "Treatments such as Enteryx align with Boston Scientific's philosophy to enhance patients' quality of life with less-invasive procedures."

    In April 2003, the U.S. Food and Drug Administration approved the Enteryx procedure 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 the commercialization of new technologies, competitive offerings, intellectual property and other factors described in the Company's filings with the Securities and Exchange Commission.