Navigation Links
Definitive Outcomes of Radiofrequency Ablation for Barrett's Esophagus Using the HALO Ablation System Reported at the Digestive Disease Week Meeting for Gastroenterologists and Esophageal Surgeons

Radiofrequency ablation is durable after 2 years, compares favorably with endoscopic resection for advanced disease, and reduces the risk for cancer progression

SUNNYVALE, Calif., June 3 /PRNewswire/ -- Results from a number of clinical trials were presented during the Digestive Disease Week (DDW) in Chicago this week, revealing new outcomes data related to endoscopic radiofrequency ablation using the HALO ablation system for eradicating a pre-cancerous esophageal condition known as Barrett's esophagus. Among them, reports included durability outcomes from a randomized sham-controlled trial, safety and efficacy outcomes from a large U.S. registry of 429 patients, a randomized trial comparing ablation to endoscopic resection, and the largest European series to date in patients with high-grade dysplasia and early cancer.

As the DDW meeting commenced, the New England Journal of Medicine published a landmark paper entitled, "Radiofrequency Ablation for Barrett's Esophagus Containing Dysplasia." This is a U.S. randomized sham-controlled trial demonstrating high rates of complete eradication of Barrett's and dysplasia in the ablation group as compared to control, as well as a significant reduction in cancer progression. At DDW, researchers presented new data from this now published trial, showing that the ablation effect achieved at 1 year follow-up was highly durable at the 2-year follow-up.

In the largest patient series to date, "Radiofrequency Ablation of Barrett's Esophagus: Outcomes of 429 Patients from a Multi-center Community Practice Registry," U.S. investigators reported a low stricture risk (about 1%) and no serious adverse events. After an average of 2 ablation procedures using the HALO ablation system and 20-month follow-up, 77% of patients were cured of their Barrett's disease. For those patients that had baseline evidence of dysplasia, 100% had complete eradication of all signs of dysplasia. These data comport with published data from predominantly tertiary referral centers.

A European multi-center randomized trial included 47 patients with Barrett's containing dysplasia and early cancer that were randomized to receive either endoscopic resection or radiofrequency ablation with the HALO ablation system. While both interventions had very high complete eradication rates (95-100%), endoscopic resection was associated with a significantly higher risk of complications. Based on these results, investigators concluded that the optimal approach is to focally resect visible lesions followed by radiofrequency ablation for complete eradication of the remaining Barrett's tissue.

In the largest European series reported to date, "Radiofrequency Ablation for Eradication of Barrett's Esophagus Containing High-Grade Dysplasia or Early Cancer: A Prospective Series of 73 Patients," researchers combined a baseline focal endoscopic resection for disease staging, and then applied serial RFA with the HALO ablation system. A complete response was achieved in 95% of patients without occurrence of serious adverse events.

"Barrett's esophagus places a patient at a significantly higher risk for developing esophageal adenocarcinoma," commented David S. Utley, M.D., chief medical officer for BARRX Medical. "Researchers at this national meeting are reporting the results of a number of well-designed clinical trials using endoscopic radiofrequency ablation to completely eradicate the Barrett's tissue. Each unique study design offers new data that continues to establish an evidence-based role for radiofrequency ablation in managing this disease state."

About BARRX Medical, Inc.

BARRX Medical, Inc. develops treatment solutions for Barrett's esophagus, a precancerous condition of the lining of the esophagus (swallowing tube) caused by gastroesophageal reflux disease, or GERD. Its main product, the HALO360 System, provides a uniform and controlled ablation effect, which removes the diseased tissue and allows regrowth of normal cells. The HALO90 System is the company's second ablation product, which is mounted on the end of an endoscope and used to treat smaller, non-circumferential areas of disease.

A multi-center randomized, sham-controlled study, published in the New England Journal of Medicine, studied 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 a significantly decreased rate of disease progression and cancer development, as compared to the control group. In another study (AIM-II) published in Gastrointestinal Endoscopy, 98.4% of patients were Barrett's-free after two and a half years of follow-up.

Both HALO systems are cleared by the FDA for use in the U.S. and both have CE Mark for use in Europe. More than 30,000 procedures have been performed in over 280 hospitals around the world. Based in Sunnyvale, Calif., BARRX Medical, Inc. was founded in 2000 and is privately-held. Additional information is available at

About Digestive Disease Week

Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers, and academicians in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 30 - June 4, 2009 in Chicago, IL. The meeting presents approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research and technology.

A list of all scientific presentations related to radiofrequency ablation for Barrett's esophagus can be found at

SOURCE BARRX Medical, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Video: ev3 Inc. Announces First Patient Enrollments in DEFINITIVE LE Post-Market Study
2. Two-Year Outcomes From Large Head-to-Head Clinical Trial Indicate Similar Safety Profile in Diabetic Patients for Cypher(R) Sirolimus-Eluting Coronary Stent and Taxus Stent
3. TAXUS WOMAN Study Reports Positive Clinical Outcomes for the TAXUS(R) Drug-eluting Stent in Women
4. New Study Demonstrates 4 Year Olds Fed Enfamil LIPIL(R) as Infants Have Brain and Eye Outcomes Similar to Breastfed Babies
5. Studies Suggest Key Correlation Between Lung Cancer Subtype and Treatment Outcomes
6. Boston Scientifics Next-Generation Stent Shows Improved Clinical Outcomes in Complex Lesions
7. Synvista Announces New Data Showing Haptoglobin Type Predicts Effectiveness of Tight Glycemic Control on Cardiovascular Outcomes in Patients with Diabetes
8. TREANDA Significantly Improves Clinical Outcomes in Patients with Chronic Lymphocytic Leukemia Compared to Chlorambucil
9. Boehringer Ingelheim Announces Enrollment is Complete for the Largest Atrial Fibrillation Outcomes Trial - The RE-LY(TM) Study
10. Cystic Fibrosis Foundation Reports Upward Trend for Key Health Outcomes
11. Outcomes Vary for Prostate Cancer Patients Choosing Surgery; Overall, No Treatment Proven Superior
Post Your Comments:
(Date:11/30/2015)... 30, 2015 ... "Orphan Drugs Market 2015-2019" report to their ... the addition of the "Orphan Drugs Market ... Research and Markets ( ) has ... Market 2015-2019" report to their offering. ...
(Date:11/30/2015)... Nov. 30, 2015   Royal Philips (NYSE: ... the industry,s first MRI guided user interface and automatic ... patients with MR Conditional implants, such as knee and ... 2015 Radiological Society of North America Annual Meeting (RSNA) ... supports diagnostic confidence of this growing patient population. ScanWise ...
(Date:11/30/2015)... November 30, 2015 ... adds a 2015 publication ... - 2015 with comprehensive analysis of ... of deal types, such as Mergers ... . ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... 2015 , ... With FCPX Overlay: Grit , users can apply a ... possibilities are truly endless, all with a click of a mouse. Each user has ... flip, depth of field and more, all within Final Cut Pro X. , With ...
(Date:12/1/2015)... (PRWEB) , ... December 01, 2015 , ... ... Contact Center Enterprise Authorized Technology Provider (ATP) status from Cisco. This designation recognizes ... and support Cisco Unified Contact Center solutions targeted to the high-end enterprise contact ...
(Date:11/30/2015)... Turks & Caicos Islands, BWI (PRWEB) , ... December 01, 2015 ... ... in 2015. Recently Caribbean Journal, one of the leading digital news sites highlighting ... The top reason? The weather. While much of North America shivers under chilly ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... the19th Bi-National Convention of the Federation of Philippine American Chambers of Commerce held ... Vegas, Nevada. , 1Heart Caregiver Services, as an active delegate from the ...
(Date:11/30/2015)... , ... November 30, 2015 , ... ... (Meso Foundation) released information for caregivers and held two webinars on topics of ... on demand free of charge at . , With a loved ...
Breaking Medicine News(10 mins):