Boston Scientific Announces Completion of Enrollment in Post-Approval Clinical Trial for the ENTERYX(R) Procedure
(March 9, 2005) -- Boston Scientific Corporation (NYSE: BSX) today announced that it has completed enrollment in its three-year ENTERYX® Procedure clinical trial. The post-approval clinical trial is designed to collect and analyze "real-world" clinical outcomes, safety data and efficacy of the ENTERYX Procedure for patients suffering from gastroesophageal reflux disease (GERD) symptoms. The trial has enrolled more than 300 patients at 28 U.S. sites. The ENTERYX Procedure was approved by the U.S. Food and Drug Administration (FDA) in April 2003. Interim results, released in November 2004 at the 69th annual meeting of the American College of Gastroenterology, supported safety and efficacy at two years.
"We continue to see significant relief of GERD symptoms in patients who have undergone the ENTERYX Procedure," said Yang Chen, M.D., the study