Study Reports 70% Of Barrett's Esophagus Patients Cured At One-Year Follow-Up In Multi-Center Study

Main Category: Acid Reflux / GERD
Also Included In: GastroIntestinal / Gastroenterology;  Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 06 Feb 2007 - 0:00 PDT

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BARRX Medical, Inc. today announced that 70% of the patients enrolled in a multi-center clinical trial were free of a precancerous condition called Barrett's esophagus one year after treatment. The data was published in the February issue of Gastrointestinal Endoscopy, a medical journal for gastroenterologists who perform advanced endoscopic procedures. In the report titled, "Circumferential Endoscopic Ablation of Barrett Esophagus using a Balloon- Based System: One-Year Follow-up of 100 Patients," patients with Barrett's esophagus were safely treated with the HALO360 Ablation System.

Barrett's esophagus is present in more than three million U.S. adults and is a complication of gastroesophageal reflux disease (GERD), a disorder affecting more than 60 million people. The current management for Barrett's esophagus includes an upper endoscopy with biopsies of the diseased tissue every one to three years. Deemed "surveillance endoscopy," this regimen is continued for the life of the patient, or until the disease is shown to progress to more dangerous stages, like dysplasia or cancer. In cases of dysplasia development, surveillance endoscopy with biopsies may be performed more frequently, every three to twelve months. If cancer progression is detected, surgical removal of the entire esophagus is recommended. According to the American Cancer Society, esophageal cancer of this type is the fastest growing cancer in the U.S. in terms of the number of new cases per year.

Virender K. Sharma, M.D., a gastroenterologist and Associate Professor of Medicine, Mayo Clinic in Scottsdale Arizona, was the first author on this study, which was co-authored by ten physicians from leading U.S. medical centers.

"Publication of the one-year results of the AIM (Ablation of Intestinal Metaplasia) Trial represents a very important milestone in the advancement of this ablative technology for our patients with Barrett's esophagus," says Dr. Sharma. "Until now, the patient with Barrett's esophagus was relegated to a lifetime of frequent endoscopic surveillance procedures to watch for progression to more dangerous forms of the disease, like dysplasia and cancer. The results of this study suggest that we can safely and proactively eliminate Barrett's esophagus at the very earliest stage, rather than limiting ourselves to passive observation of the disease for progression. This has been a welcome change in the management strategy for our patients with Barrett's esophagus."

In this study, patients with the earliest stage of Barrett's esophagus (intestinal metaplasia) received ablation using the HALO360 Ablation System, a balloon-based radiofrequency device designed to remove the diseased cells using controlled heat.

The procedures were performed non-surgically, using endoscopy, which allowed the patient to return to normal activity after treatment. Follow-up visits over 12 months included frequent endoscopy with biopsy procedures to determine if the disease was fully eliminated. At one year, 70% of patients were cured of Barrett's, while the remaining patients had near-complete resolution of their disease.

"The results of the AIM Trial prompted BARRX Medical to develop a focal ablation device, called the HALO90 Ablation System, which can be used as a complimentary therapy to circumferential ablation with the HALO360 device," said David S. Utley, M.D., Chief Medical Officer, BARRX Medical, Inc. "The AIM Trial has been extended beyond that which is reported in this current publication in order to remove any residual Barrett's with the new device. With patient follow-up now approaching 2.5 years for the trial, it is expected that the focal ablation procedure will even further improve the efficacy outcomes of this ablative technology."

About BARRX Medical, Inc.

BARRX Medical, Inc. develops treatment solutions for Barrett's esophagus. Its first product, the HALO360 Ablation System, uses a balloon-based electrode to ablate Barrett's tissue circumferentially within the esophagus. A newer product from BARRX Medical, the HALO90 Ablation System, is an electrode system that is mounted on the end of an endoscope, allowing the physician to treat focal areas of diseased tissue. Both HALO Systems provides uniform and controlled therapy at a consistent depth, which can remove Barrett's esophagus and allow the regrowth of normal cells. Both systems are cleared by the U.S. Food and Drug Administration and are commercially available. Based in Sunnyvale, Calif., BARRX Medical, Inc. was founded in 2000 and is a privately held company. Additional information about BARRX Medical, Inc. and the HALO360 System is available at http://www.barrx.com/.

About Gastrointestinal Endoscopy

Gastrointestinal Endoscopy, the official publication for the American Society for Gastrointestinal Endoscopy, publishes original, peer-reviewed articles on endoscopic procedures used in the study, diagnosis, and treatment of digestive diseases. Gastrointestinal Endoscopy has become the international forum for the newest developments in the specialty, bringing readers challenging reports from leading authorities throughout the world.

BARRX Medical, Inc.
http://www.barrx.com/