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Stretta Procedure Found to Be Highly Effective in Treating Gastroesophageal Reflux Disease in Obese Patients

FREMONT, CA -- June 2, 2004 -- The Stretta procedure is highly effective in treating gastroesophageal reflux disease (GERD) in obese patients as well as in those who had previously undergone unsuccessful anti-reflux surgery, according to clinical data presented by Curon Medical, Inc. the manufacturer of the Stretta system, in Chicago today at the 2004 annual meeting of the Central Surgical Association (CSA).

The principal investigator of the study, "Delivery of Radiofrequency Energy to the Lower Esophageal Sphincter Improves Symptoms of Gastroesophageal Reflux", was W. Scott Melvin, MD, Chief of the Division of General Surgery and Director of the Center for Minimally Invasive Surgery at The Ohio State University Medical Center (OSUMC).

"Prior to undergoing the Stretta procedure, all 50 patients in our study reported significant GERD symptoms despite compliance with a daily drug regimen," said Dr. Melvin. "We intentionally included a group of difficult to treat GERD patients. Among these were ten patients who had previously undergone anti-reflux surgery, but still had persistent or recurrent GERD symptoms, as well as 18 patients who were obese (BMI>30) and therefore considered poor surgical candidates. While the entire group demonstrated significant symptom improvement overall following the Stretta procedure, we were particularly pleased with the significant symptom improvement seen in the sub-group of obese patients, and in the group who had failed previous anti-reflux surgery," added Dr. Melvin.

Dr. Michael Go reported the results of this study, which was composed of 50 GERD patients treated at OSUMC over a two and a half year period. The primary end-point of the study was symptom improvement. Following the Stretta procedure, the entire group of patients demonstrated a significant improvement in the mean heartburn score (3.19 to 1.74, p=.0012), and the overall symptom score (3.92 to 1.63, p=.0001). Obese patients with a body mass index (BMI) greater than 30, who are not considered to be good candidates for surgery because of their obesity, also did significantly better following the Stretta procedure; with a reduction in mean heartburn score from 3.5 to 1.2 (p=.0057) and improvement in their overall symptom score from 4.11 to 1.56 (p=.0024).

"This report from Ohio State University Medical Center is an important addition to the already substantial body of clinical evidence regarding the safety and efficacy of the Stretta procedure," said Larry C. Heaton II, President and Chief Executive Officer of Curon Medical Inc. "Dr. Melvin's investigation provides further evidence that the Stretta procedure offers GERD symptom control for difficult to treat patients. He has shown that obese patients, as well as patients in whom anti-reflux surgery has failed, achieve significant relief from GERD symptoms with the Stretta procedure. This becomes particularly relevant when reviewing data from the Scandinavian study published in the July 2, 2003 edition of the Journal of the American Medical Association (JAMA), that indicated that persons who are overweight or obese may be up to six times more likely to have GERD than persons of normal body weight," concluded Mr. Heaton.

About The Stretta System

Curon Medical's proprietary Stretta System provides physicians with the tools to perform a minimally invasive, outpatient endoscopic procedure for the treatment of GERD. The Stretta System consists of the Stretta Catheter, which is a disposable, flexible catheter and the Curon Control Module. Using the Stretta System, the physician delivers temperature-controlled radiofrequency energy to create thermal lesions in the muscle of the lower esophageal sphincter (LES). The tissue response to radiofrequency delivery alters LES function, which results in statistically significant improvements in GERD symptom scores, reduction in acid exposure and reduction in anti-secretory medication requirement.


SOURCE Curon Medical, Inc.

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