Ablative Therapy With HALO360 Effective Treatment For Barrett's Esophagus
BARRX Medical announced that 90.2 percent of the patients in a multi-center US study were free of the highest-risk of Barrett's esophagus after having a non-surgical, endoscopic treatment using the HALO360 ablation system. Barrett's esophagus afflicts more than three million U.S. adults and is a complication of gastroesophageal reflux disease (GERD). The abnormal Barrett's tissue is the precursor to esophageal cancer (adenocarcinoma), which has the fastest rising incidence of all cancers in the U.S.
This study is currently online and appearing in an upcoming issue of Gastrointestinal Endoscopy, a medical journal for gastroenterologists who perform advanced diagnostic and therapeutic endoscopic procedures. In the report titled, "Circumferential Ablation of Barrett's Esophagus Containing High-Grade Dysplasia: A U.S. Multi-Center Registry," 142 patients with the most advanced stage of Barrett's esophagus -- called high grade dysplasia -- were treated with the HALO360 Ablation System and had a 90.2% clearance rate. This unique, catheter-based technology applies a controlled amount of heat energy to the diseased tissue of the esophagus, resulting in restoration of a normal esophageal lining in the majority of patients.
"The results of our trial confirm that this sub-type of Barrett's esophagus having the highest-risk of becoming cancer can be safely and effectively treated," said Abbott Northwestern Chief of Gastroenterology and Associate Professor of Medicine, Robert Ganz, M.D., of Minneapolis, MN. Dr. Ganz led the study which was co-authored with specialists at 15 other leading U.S. medical centers. "We're confident this treatment can sharply reduce the number of patients who have an esophagectomy, which has historically represented the standard of care for patients with high grade dysplasia." An esophagectomy is surgical removal of the entire esophagus.
This study was conducted prior to availability of the HALO90 Ablation System, an adjunctive device that is utilized to treat small areas of residual disease after the initial therapy. In the largest study conducted with these devices working together, 98.4 percent of patients had complete elimination of all Barrett's tissue at 2.5 years of follow-up from initial therapy.
Recent studies have shown a significant further increase in response to therapy when combining the HALO360 and HALO90 modalities in a step-wise manner.