Follow-Up Data Support Enteryx's Safety, Efficacy

ORLANDO, FLA. — Enteryx, an implantable copolymer approved by the Food and Drug Administration for the treatment of gastroesophageal reflux disease symptoms in 2003, appears to have durable efficacy and safety, David Johnson, M.D., reported in a poster at the annual meeting of the American College of Gastroenterology.

Of 300 patients participating in a 36-month, FDA-mandated postmarket study, 64 patients have completed 24 months of follow-up. Of these, 43 completely eliminated the use of proton pump inhibitor therapy and 3 others reduced their use of PPI therapy by at least 50%, said Dr. Johnson of Eastern Virginia School of Medicine, Norfolk.

The patients, who had well characterized GERD symptoms and were PPI dependent prior to the injection of Enteryx (Boston Scientific Corp.) into the lower esophageal sphincter, also had a median improvement of 80% in GERD health-related quality of life heartburn scores, and a median improvement of 88% in regurgitation scores, compared with baseline scores prior to initiation of PPI therapy, he noted.

No new device-related adverse events occurred during follow-up, and the observed clinical benefits were stable at 6, 12, and 24 months, he said.