NEW ORLEANS, May 5 Results from two major multi-center clinical trials presented at the Digestive Disease Week in New Orleans independently confirmed that the effects of endoscopic radiofrequency ablation (RFA) for eradicating a pre-cancerous condition of the esophagus called Barrett's esophagus are durable in the long-term. In a plenary scientific presentation titled "Endoscopic Radiofrequency Ablation for Barrett's Esophagus: Five-year Durability Outcomes from a Prospective Multi-Center Trial," patients with Barrett's esophagus were treated with endoscopic RFA using the HALO system. Endoscopic RFA is a non-surgical procedure performed on an outpatient basis. Five years after enrollment and treatment, 92% of patients were free of all Barrett's tissue. All remaining patients (8%) were restored to a Barrett's-free state with a single session of focal ablation.
In a separate scientific presentation titled "Durability of Epithelial Reversion After Radiofrequency Ablation: Follow-up of the AIM Dysplasia Trial," investigators presented the longer-term results of a clinical trial for which the one year data was published in 2009 in the New England Journal of Medicine. Patients had advanced stages of Barrett's esophagus, deemed dysplasia, and were treated with endoscopic RFA using the HALO system either at study entry or after cross-over from a sham control study arm. At 2-3 years after enrollment and treatment, more than 90% of patients were free of all Barrett's tissue.
Barrett's esophagus is cellular change in the lining of the esophagus caused by chronic injury due to gastroesophageal reflux disease (GERD). The cellular change places the patient at a significantly increased risk for developing esophageal cancer, between 200 and 6,660 times that of the general population depending on the severity of the Barrett's diagnosis. Cancer of the esophagus is the seventh leading cause of cancer death in the U.S. and has displayed a rapid rise in annual incidence.
"There is a growing body of published data which demonstrate that RFA for dysplastic and non-dysplastic Barrett's esophagus is safe, effective, and cost-effective," commented David S. Utley, M.D., chief medical officer for BARRX Medical. "These new data provide additional evidence that the treatment effect of RFA for Barrett's esophagus is durable in the long-term."
About BARRX Medical, Inc.
BARRX Medical, Inc. develops treatment solutions for Barrett's esophagus and other chronic gastrointestinal disease states. Barrett's esophagus is a precancerous condition of the lining of the esophagus (swallowing tube) caused by gastroesophageal reflux disease, or GERD. The company's HALO360 and HALO90 ablation systems, as well as its new HALOFLEX ablation system, deliver a uniform and controlled ablation effect to the esophageal lining, which removes diseased tissue and allows regrowth of normal cells.
A multi-center randomized, sham-controlled study, published in the New England Journal of Medicine, studied HALO radiofrequency ablation applied in the highest risk Barrett's population (those having dysplasia). The ablation group had a high rate of complete eradication of dysplasia and intestinal metaplasia and significantly decreased the rate of disease progression and cancer development, as compared to the control group.
The HALO systems are cleared by the FDA for use in the U.S. and both have CE Mark for use in Europe. More than 52,000 procedures have been performed in over 350 hospitals around the world. Based in Sunnyvale, Calif., BARRX Medical, Inc. was founded in 2000 and is privately-held. Additional information is available at www.barrx.com.
SOURCE BARRX Medical, Inc.