SUNNYVALE, California - Radiofrequency ablation is durable after 2 years, compares favorably with endoscopic resection for advanced disease, and reduces the risk for cancer progression
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 www.barrx.com.
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 www.barrx.com
Source: BARRX Medical, Inc.
media, Kevin Knight, +1-972-385-9384, M, +1-214-732-9392, kmcinc at aol.com, for BARRX Medical, Inc.; or Gregory A. Barrett of BARRX Medical, Inc., +1-408-328-7308, gbarrett at barrx.com
Related Press Releases
A Swiss Team Uses Transcranial MR-Guided Focused Ultrasound to Treat Patients With Functional Brain DisordersJuly 13th, 2009 TIRAT CARMEL, Israel -
- Ten-Patient Feasibility Study Shows Safety and Potential for Non-Invasive Deep Brain Ablation
InSightec Ltd. today announced that a team at the University Children's Hospital Zurich has completed a feasibility study testing the use of non-invasive transcranial MR-guided focused ultrasound surgery (MRgFUS) for the treatment of neuropathic pain.
Can Bacteria be Good for Your Dog?July 7th, 2009 GENEVA - Your dog's intestinal tract contains 65% of his immune system and contains both good and bad bacteria, the balance which is central to his health and well being. We are all aware of bacteria that cause illness but equally there are bacteria that can actually be good for your dog.
/C O R R E C T I O N -- Biosense Webster, Inc./June 21st, 2009 BERLIN - In the news release, "Biosense Webster to Showcase CARTO(R) 3 System at Eurospace" issued on 22 Jun 2009 09:31 GMT, by Biosense Webster, Inc. over PR Newswire, we are advised by a representative of the company that in the headline "Eurospace" should have been written as "Europace".
Biosense Webster to Showcase CARTO(R) 3 System at EurospaceJune 21st, 2009 BERLIN - State-of-the-Art Navigational Mapping System Offers Unique Combination of Accuracy, Speed and Efficiency
BERLIN, June 22 /PRNewswire/ --
Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, will showcase the CARTO(R) 3 System, the most advanced three-dimensional imaging technology for use by electrophysiologists in treating cardiac arrhythmias, commonly referred to as irregular heart rhythms, here at EUROPACE, the official Congress of the European Heart Rhythm Association. "The CARTO(R) 3 System is the world's most advanced 3D mapping platform and builds upon our long-standing commitment to electrophysiologists and their patients," said Shlomi Nachman, Worldwide President, Biosense Webster, Inc.
Advance in Bowel Cancer Test ResearchJune 4th, 2009 SYDNEY - Australian researchers have developed gene expression biomarkers which can accurately discriminate pre-cancerous and cancerous colorectal growths from non-cancerous controls. Being presented today at the Digestive Disease Week conference in Chicago, the preliminary findings are the result of a collaborative study - involving CSIRO, Flinders University and Australian healthcare company, Clinical Genomics Pty Ltd - designed to develop an improved screening/diagnostic test for detecting bowel cancer and significant pre-cancer lesions.
Researchers Present Safety and Efficacy Results of 429 Patients Treated With Radiofrequency Ablation for Pre-Cancerous Barrett's EsophagusMay 31st, 2009 SUNNYVALE, California - Large multi-center trial conducted in a community practice setting demonstrates comparable outcomes as trials conducted in predominantly tertiary academic centers
Clinical trial results presented at the Digestive Disease Week in Chicago today reveal that endoscopic radiofrequency ablation performed in a community practice setting is safe and effective for eradicating a pre-cancerous esophageal condition known as Barrett's esophagus. The study is entitled, "Radiofrequency Ablation of Barrett Esophagus: Outcomes of 429 Patients from a Multi-center Community Practice Registry" and was presented today by Ronald E.
Study in the New England Journal of Medicine Shows Non-Surgical Treatment for Pre-Cancerous Condition of Esophagus is Effective and Reduces Risk for Cancer DevelopmentMay 27th, 2009 SUNNYVALE, California - Data show superiority of endoscopic ablation therapy using the HALO System for eradicating Barrett's esophagus in randomized, multicenter, sham controlled trial
Results from a clinical study published today in the New England Journal of Medicine reveal that ablative therapy using the HALO system (BARRX Medical, Inc.) is highly effective for complete eradication of a pre-cancerous condition of the esophagus called Barrett's esophagus afflicting more than 3.3 million Americans. Additionally, ablative therapy using the HALO system reduced the risk of progression to cancer in the highest risk cohort studied (compared to control) from 19.0% to 2.4%.
The Hidden Heart ProblemMay 26th, 2009 LONDON - YouGov Survey Reveals Low Awareness of Potentially Fatal Heart Condition That Affects Significant Number of People in UK
LONDON, May 27 /PRNewswire/ --
As many as 700,000 people in the UK suffer from a heart abnormality called arrhythmia, a potentially fatal condition, which the majority of Londoners have never heard of - according to a recent survey conducted by YouGov[1]. Many of the deaths associated with arrhythmias could be prevented due to advances in the identification and treatment of high risk patients.
Pershing Square Capital Management to Host Town Hall Meeting on May 11, 2009 for All Target Shareholders and Interested PartiesMay 5th, 2009 NEW YORK - Advanced Registration is Required
Pershing Square Capital Management, L.P., announced today that it will host a Town Hall Meeting to provide all shareholders of Target Corporation (NYSE: TGT) and other interested parties the opportunity to meet each of its nominees for the Target Board of Directors. As seating is limited, in-person attendees must register in advance.
NHS National Innovation Centre Cites VNUS Closure(R) Procedure as Select Innovative TechnologyApril 2nd, 2009 SAN JOSE, California - Minimally Invasive Treatment for Varicose Veins to be showcased at National Health Service EXPO
VNUS(R) Medical Technologies, Inc. (Nasdaq: VNUS), a worldwide leader in medical devices for the minimally invasive treatment of venous reflux disease, today announced that the UK NHS National Innovation Centre has identified the VNUS Closure(R) procedure as a select innovative technology that is bringing benefits to National Health Service (NHS) hospitals and patients.
Related News
Cervical Dysplasia at a glanceAugust 5th, 2009 Definition: Cervical dysplasia also known as Cervical intraepithelial neoplasia (CIN), is actually a Precancerous or abnormal changes of the cells in the lining of the cervix at the opening of the womb or uterus. Causes:
Along with other factors cervical dysplasia is mainly caused by infection with the human papillomavirus (HPV) which is a very common infection in the general population.
Laser op can end that stinky sweat from armpit for goodMarch 12th, 2009 LONDON - British surgeons are offering to permanently treat excessive armpit perspiration with the aid of a new 60-minute laser operation. he Laser Sweat Ablation service, launched on Monday, will cost around 3,500 pounds.
Morocco's royal doctor orders King Mohammed VI to convalesce 5 days for digestive virusAugust 27th, 2009 Morocco's king convalescing with digestive virusRABAT, Morocco — The Moroccan royal palace says a doctor has ordered King Mohammed VI placed in convalescence for five days for a digestive infection. A palace statement carried by the state news agency MAP cites palace doctor Abdelaziz Maauni as saying the infection poses "no concerns for his health."
MAP says the king has a rotavirus infection with acute dehydration.
Aspirin improves survival in women with heart diseaseMarch 16th, 2009 WASHINGTON - Researchers have come by additional evidence that aspirin seems to reduce the risk of death in women who have heart disease or have had a stroke. The new study also provides fresh insight into aspirin dosing for women, suggesting that a lower dose of aspirin (81 mg) is as effective as a higher dose (325 mg).
Music 'soothes pain of premature babies'May 28th, 2009 WASHINGTON - Playing music to babies can help reduce pain and encourage better oral feeding, a new study suggests. The research, published ahead of print in the Archives of Disease in Childhood, claimed that increasing numbers of neonatal units are using music as a method to help improve behavioural and physiological outcomes or to manage pain during common procedures such as circumcision.
New tool studies hair to say what one ate, where one travelledMay 28th, 2009 LONDON - Variation in sulphur concentration in the hair can reveal one's recent diet and the places one has been to. A new laser tool based on this can be very handy to investigators tracking terrorists.
Review: 'Halo 3: ODST' brings plenty of firepower, but nothing fresh to the epicSeptember 22nd, 2009 'Halo 3: ODST': Lots of firepower, nothing freshThe "Star Wars" movies should have taught all science-fiction writers a lesson: One trilogy is enough. Bungie, the developer of Microsoft's blockbuster "Halo" trilogy, wrapped up the story in 2007.
WHO working on formulas to model spread of swine flu as actual cases outpace reported numbersJuly 1st, 2009 WHO working on formulas to model swine flu spreadGENEVA — The World Health Organization said Wednesday it is working to mathematically model the spread of swine flu in an attempt to better understand how the outbreak developed from a handful of cases to a global epidemic in less than two months. WHO brought together over 20 independent experts beginning Wednesday for the three-day meeting in Geneva.
Gamers line up to play 'Legend of Zelda,' 'God of War' sequels at E3June 4th, 2009 Gamers line up for 'Halo,' 'God of War' sequelsLOS ANGELES — Gamers at the Electronic Entertainment Expo are sticking with what they know. The longest lines at E3, the three-day trade show wrapping up Thursday in Los Angeles, have been for glimpses of the next installments in long-running franchises such as Nintendo's "Legend of Zelda" and Sony's "God of War" series.
Michael Jackson suffering from flesh-eating disorderFebruary 11th, 2009 LONDON - Pop star Michael Jackson is suffering from MRSA skin disease, which could eat his flesh. According to thesun.co.uk, Jackson has been receiving antibiotics through drip and the disease has apparently spread throughout his body.
