ENTERYX® Procedure Effective in Controlling the Symptoms of GERD
May 23, 2005 - 10:41:38 AM
Boston Scientific Corporation (NYSE: BSX) announced results of four clinical trials demonstrating patient satisfaction with, and effectiveness of, the ENTERYX® Procedure in relieving the symptoms of gastroesophageal reflux disease (GERD). Results were presented in oral and poster sessions at the Digestive Disease Week® (DDW®) 2005 conference, held in Chicago May 14-19.
These clinical trial results demonstrate the safety and efficacy of the ENTERYX Procedure at controlling GERD symptoms, and show that the ENTERYX Procedure contributes to high levels of patient satisfaction as compared to daily proton pump inhibitor ( PPI ) treatments, said Glen Lehman, M.D., Professor of Medicine and Radiology, Associate Director of Clinical Affairs, Department of Medicine, Indiana University Medical Center. The growing body of clinical data suggests that the ENTERYX Procedure has a place in the treatment algorithm for chronic GERD sufferers.
Boston Scientific is very pleased to present such a broad collection of data on the ENTERYX Procedure, said Steve Moreci, Boston Scientific Senior Vice President and Group President, Endosurgery. These studies confirm the value of the ENTERYX procedure as a safe and effective treatment option for appropriate patients who suffer from chronic GERD symptoms. We are committed to providing the medical community with additional data from clinical trials.
Studies presented at DDW included the following key findings:
-- Patients were more satisfied and achieved better control of GERD symptoms with the ENTERYX Procedure than with PPI use.
Reporting interim results from the study, GERD Symptoms and Treatment Satisfaction Among ENTERYX Patients ( Presentation # S1167 ), David Johnson, M.D., Professor of Medicine, Chief of Gastroenterology, Eastern Virginia School of Medicine, Norfolk, VA, showed that compared to proton pump inhibitor therapy ( PPI ) used prior to the ENTERYX Procedure, patients were more satisfied and achieved better control of their GERD symptoms with the ENTERYX Procedure according to satisfaction questions administered at baseline on PPIs and at study follow-up visits after ENTERYX treatment.
Using a GERD-specific questionnaire, patients reported substantial improvement in GERD symptom control and relief, freedom to eat and drink, ability to sleep better and higher overall rates of treatment satisfaction with the ENTERYX Procedure compared to their prior experience on PPI medications. The study, which included follow-up assessments at one and six months following the ENTERYX Procedure, enrolled 322 patients in two post-market, multi-center studies.
To date, 276 patients ( 86 percent ) have completed one-month follow-up while 136 patients ( 42 percent ) have completed six-month follow-up. Results for the 136 patients who completed the six-month follow-up show that the mean GERD-HRQL ( Health Related Quality of Life ) symptom score improved significantly from 19.4 at baseline to 9.6 at six months post-procedure ( p less than 0.0001 ).
-- Nearly two-thirds of 46 patients were able to reduce or discontinue their PPI use as well as maintain GERD symptom control after three years.
Presenting interim results from the study, Endoscopic Implantation of ENTERYX for the Treatment of GERD: 36-Month Follow-Up in 46 U.S. Subjects ( Presentation # 327 ), Dr. Lehman reported PPI use for 46 patients who currently were available for evaluation. This multicenter, FDA-mandated, post-market study of 300 patients assessed safety and effectiveness of the ENTERYX Procedure at 36 months following treatment. At 36 months, 29 patients ( 63 percent ) had reduced their PPI use by at least 50 percent, including 25 patients ( 54 percent ) who had completely eliminated PPI use. Mean 36-month GERD-HRQL heartburn and regurgitation scores significantly improved ( p<0<0<0
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