Boston Scientific Completes Enrollment in Enteryx Procedure Clinical Trial

Strategic Insights -

Boston Scientific Corporation has completed enrollment in its 3-year Enteryx Procedure clinical trial, designed to analyze the safety and efficacy of the procedure for patients with gastroesophageal reflux disease (GERD) symptoms. The study has enrolled over 300 patients at 28 U.S. sites, building on the Enteryx Procedure's FDA approval in April 2003. Interim results released in November 2004 demonstrated safety and efficacy at 2 years, and trial investigators are optimistic that final results will confirm the procedure as an effective treatment option. Approximately 60 million people in the United States suffer from GERD symptoms, which can lead to persistent and severe heartburn, inflammation, and potentially even esophageal cancer.

Key Takeaways:

  • The Enteryx Procedure is an outpatient procedure that typically takes less than 1 hour to complete, involving the injection of a liquid copolymer into the muscle layer of the esophagus to help the lower esophageal sphincter (LES) form a more effective barrier.
  • The procedure is designed to reduce GERD symptoms, which affect approximately 60 million people in the United States.
  • Interim results from the 3-year clinical trial at 2 years demonstrated safety and efficacy of the Enteryx Procedure.
  • The study's principal investigator, Yang Chen, MD, expects that the final results will confirm the procedure as an effective and durable treatment option for patients suffering from GERD symptoms.
  • Steve Moreci, Senior VP and Group president, Endosurgery at Boston Scientific, stated that the Enteryx Procedure aims to improve patients' quality of life through a less-invasive approach.

Statistics:

  • The Enteryx Procedure clinical trial has enrolled over 300 patients at 28 U.S. sites.
  • Approximately 60 million people in the United States suffer from GERD symptoms (Source: "Enteryx Procedure" article)
  • The Enteryx Procedure is an outpatient procedure that typically takes less than 1 hour to complete.
  • The study's principal investigator, Yang Chen, MD, expects that the final results will confirm the procedure as an effective and durable treatment option for patients suffering from GERD symptoms.

Sources:

  • Boston Scientific Corporation (BSX) press release regarding completion of enrollment in the Enteryx Procedure clinical trial.
  • Health & Medicine Week editors, "Boston Scientific Completes Enrollment in Enteryx Procedure Clinical Trial" (2005).
  • NewsRx.com, "Enteryx Procedure" article (2005)