Barrx Treatment Group Significantly Outperforms Control in Barrett’s Esophagus

Results of a new clinical study into the Barrx RF Ablation platform, acquired by Covidien back in late 2011, say the therapy is effective at treating Barrett’s esophagus.

Background

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.

Covidien’s Barrx RF Ablation System is used as part of an endoscopic 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.

The March 25 JAMA publication announced results from the SURF Trial (SUrveillance vs. RadioFrequency 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.

The researchers found that ablation was associated with reduced absolute risk of progression to high-grade dysplasia or cancer of 25 percent (1.5 percent vs 26.5 percent for control) and a reduced absolute risk of progression to cancer of 7.4 percent (1.5 percent vs 8.8 percent). Complete eradication of dysplasia occurred and persisted in the majority of patients in the ablation group.

Investigator comments

“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.”

Source: Covidien plc, Business Wire

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