Boston Scientific Announces ENTERYX Trial Enrollment Completion

Boston Scientific has completed enrollment in its three-year ENTERYX Procedure clinical trial, designed to collect and analyze "real-world" clinical outcomes, and safety and efficacy data on the ENTERYX Procedure for patients suffering from gastroesophageal reflux disease (GERD) symptoms.

Patients enrolled in the ENTERYX Procedure postapproval trial have responded to and are in need of daily treatment with proton pump inhibitors (PPI). Baseline pretreatment parameters such as PPI use and GERD-Health-Related Quality of Life score are compared to outcomes after treatment with the ENTERYX Procedure through three years.

The trial has enrolled more than 300 patients at 28 U.S. sites. The ENTERYX Procedure was approved by the 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.