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Enteryx Procedure Shows Safety and Ongoing Relief of Acid Reflux at 24-Months: Presented at DDW

By Bruce Sylvester

NEW ORLEANS, LA -- May 21, 2004 -- The Enteryx® procedure is safe and effective for the relief of the symptoms of gastroesophageal reflux disease (GERD) up to 24 months after treatment, researchers reported here on May 18^th at the Digestive Diseases Week Annual Meeting.

"We found data suggesting that, after application of the Enteryx procedure, GERD symptoms are being managed effectively and safely for up to 2 years, the end point of this study," said David. Johnson, MD, Professor of Medicine, and Chief of Gastroenterology, Eastern Virginia School of Medicine, Norfolk, Virginia. "Importantly, this study further supports the Enteryx procedure as an effective alternative to daily drug treatment relief of GERD symptoms."

The primary objective of the study was to assess the extended safety and efficacy in patients with GERD treated with Enteryx, a nonbiodegradable polymer that is implanted into the lower esophageal wall.

Previous studies have shown the clinical benefits of the procedure, including elimination or reduction in the use of proton pump inhibitors (PPIs) and improvements in health-related quality of life at 6 and 12 months after implantation. Dr. Johnson and colleagues conducted their study to determine whether the clinical benefits would persist 24 months after the procedure.

In April 2003, the United States Food and Drug Administration approved the Enteryx procedure for the treatment of symptoms of GERD in patients responding to and requiring daily pharmacological therapy with PPIs. The ongoing FDA-mandated Post Market Study includes 300 patients in the U.S. who are being followed to 3 years.

The study was open to enrollment by any U.S. patient previously treated in the Investigational Device Exemption multicenter trial or patients receiving Enteryx® treatment with GERD who were responsive to and requiring daily PPI therapy. The investigators excluded patients with esophageal varices, particularly related to portal hypertension, and patients who were determined to be poor candidates for endoscopy and/or anesthesia.

The primary study end point was the proportion of subjects who had stopped PPI use or reduced PPI dose by at least 50% at 12, 24, and 36 months. Follow-up data was gathered at months 1, 6, 12, 24, 36 for assessment of PPI use, GERD symptom scoring, and adverse events. More safety-related data has been collected quarterly following Enteryx® treatment.

Twelve-month data were published in the American Journal of Gastroenterology (2003;99:250).

Data on 26 patients at 24-months show that 84.6% of patients met the primary objective, 65.4% discontinued their use of PPIs and 19.2% reduced their PPI use by at least 50%; 3.8% reduced PPI use by less than 50%, and 11.6% continued to use their PPI as before the procedure. There were no new device-related adverse events reported from 12 to 24 months.

"From this data we now know that there is a single, safe, outpatient procedure that is effective for these patients out to two years, and it does not adversely affect future surgery or PPI use, should those be needed," added Gregory Haber, MD, Director, Division of Gastroenterology, Lenox Hill Hospital, New York. "We look for ward to seeing the 36-month data on these patients."

The research was supported by Boston Scientific


[Presentation title: "Enteryx®: 24-month clinical safety and effectiveness." Abstract #104770]

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