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DURABILITY AND LONG-TERM SAFETY OF ENTERYX® IMPLANTATION FOR GERD

24-MONTH FOLLOW-UP OF A PROSPECTIVE MULTICENTER TRIAL

904

Johnson, David A., M.D., F.A.C.G.; Aisenberg, James, M.D.; Cohen, Lawrence B., M.D., F.A.C.G.; Foley, T. Raymond, M.D.; Ganz, Robert A., M.D.; Lehman, Glen A., M.D., F.A.C.G.*

American Journal of Gastroenterology: October 2004 - Volume 99 - Issue 10 - p S296
Abstracts Submitted for the 69th Annual Scientific Meeting of the American College of Gastroenterology: October 29–November 3, 2004, Orlando, Florida: ENDOSCOPY
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Eastern VA School of Medicine, Norfolk, Virginia; Mount Sinai Hospital, New York, New York; Lancaster General Hospital, Lancaster, Pennsylvania; Minnesota Clinical Research Center, Minneapolis, Minnesota and Indiana University Medical Center, Indianapolis, Indiana.

Purpose: To assess the effectiveness, durability, and long-term safety of Enteryx®, a biocompatible copolymer implanted into the region of the lower esophageal sphincter for the treatment of GERD symptoms.

Methods: Subjects were part of an FDA-mandated Post Market Study designed to follow 300 patients for 3 years after Enteryx treatment. To date, 64 patients completed 24 mo of follow-up in this multicenter trial. Study patients had well characterized GERD symptoms and were PPI-dependent. Exclusion criteria included esophageal varices, particularly related to portal hypertension, and patients determined to be poor candidates for endoscopy and/or anesthesia. The primary study endpoint was the patient proportion at 12 and 24 months who eliminated PPI use or reduced PPI dose by >50%. Secondary objective was GERD health-related quality of life (GERD-HRQL) score assessment. Follow-up occurred at month 1, 6, 12, 24, 36. Safety information was collected quarterly.

Results: In 64 patients followed for 24 months post Enteryx implantation, 46 patients (71.9%; CI, 60.9-82.9%) reduced PPI use by >50%, of which 43 patients (67.2%; CI, 54.3-78.4%) completely eliminated daily PPI use. GERD-HRQL heartburn score was also improved by a median of 79.8% (CI, 71.2-87.4%) at 24 mo compared with baseline off PPIs, and median regurgitation score improvement was 87.5% (CI, 78.6-91.7%). There were no new device-related adverse events reported at any point tracking back to the baseline treatment date. The observed clinical benefits were relatively stable at 6, 12, and 24 months.

Conclusions: Enteryx effectiveness remains durable at 24 months and appears consistent with the success rates evident at 6 and 12 months. The extended safety data remains excellent. This extended follow-up shows no significant waning of benefit or new safety concerns. The preliminary support for the short term (6 and 12 month) efficacy and safety of Enteryx is supported by this longer term follow-up.

© The American College of Gastroenterology 2004. All Rights Reserved.