An innovative Covidien (NYSE: COV) technology is effective at treating Barrett’s esophagus (a precancerous condition of the esophagus), according to a clinical study published in The Journal of the American Medical Association (JAMA).
The March 25 JAMA publication announced results from the SURF Trial ( SUrveillance vs. Radio Frequency ablation). SURF was a multi-center, randomized, investigator-sponsored clinical trial that compared the Covidien Barrx™ RF Ablation System with endoscopic surveillance in patients with Barrett’s esophagus and a confirmed diagnosis of low-grade dysplasia. The study enrolled 136 patients at nine European sites between June 2007 and June 2011.
“In patients with Barrett’s esophagus containing confirmed low-grade dysplasia, endoscopic ablation significantly reduced disease progression to high-grade dysplasia and esophageal cancer as compared to surveillance alone,” said principal investigator Jacques Bergman, M.D., Ph.D., professor of Gastrointestinal Endoscopy, director of Endoscopy, Academic Medical Center, Amsterdam, The Netherlands. “The difference in the disease progression outcome between the two groups was so large, in fact, that the data safety monitoring board overseeing the trial recommended early stoppage of the trial and patients in the control group were then offered endoscopic ablation.”
Barrett’s esophagus develops as a result of chronic injury from gastroesophageal reflux disease (GERD). The normal esophageal lining is replaced with abnormal cells (known as Barrett’s tissue), putting patients at greater risk of developing cancer of the esophagus. Patients with Barrett’s who ultimately develop cancer typically do so through a series of steps, starting with early Barrett’s, then low-grade dysplasia or high-grade dysplasia and then cancer.The SURF Trial was supported, in part, by a grant from Covidien GI Solutions and the Maag Lever Darm Stichting grant (WO 07-06) from the Dutch Digestive Diseases Foundation. Covidien’s Barrx RF Ablation System is used as part of an endoscopic (non-surgical) procedure and uses radiofrequency energy to coagulate tissue and remove the Barrett’s epithelial tissue. In the United States, the Barrx system is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett’s Esophagus, Dieulafoy Lesions, and Angiodysplasia.