SUNNYVALE, California, June 1, 2010 /PRNewswire/ -- BARRX Medical Inc., a leader in the development of minimally invasive medical devices designed to remove precancerous tissue from within the gastrointestinal tract, reported today that the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) has issued a new practice guideline for the surgical treatment of gastroesophageal reflux disease (GERD). Left untreated, reflux of stomach contents such as acid and bile into the esophagus in GERD patients often leads to injury and chronic inflammation of the lining of the esophagus. A significant proportion of GERD patients are thus predisposed to developing precancerous changes within the esophageal lining, a condition called Barrett's esophagus, which can lead to esophageal adenocarcinoma. In addition to providing recommendations for the surgical management of GERD, the new SAGES guideline presents a number of evidence-based recommendations for the management of Barrett's esophagus when it develops in these patients.
The authors of the SAGES practice guideline provided a series of systematically developed recommendations related to the management of GERD and Barrett's esophagus based upon a rigorous review of all relevant published scientific studies. Specific to the management of Barrett's esophagus, the practice guideline deemed that patients with the most advanced stages of Barrett's esophagus (high-grade dysplasia and intramucosal cancer) may be treated with endoscopic therapy inclusive of radiofrequency ablation (RFA) and/or endoscopic mucosal resection. Surgery remains an option for these patients as salvage or primary therapy. For Barrett's patients with earlier stages of disease (non-dysplastic and low-grade dysplasia), the practice guideline states that RFA has been shown to be safe, clinically effective, and cost-effective in these disease states.
I am pleased that SAGES's new practice guideline for the surgical treatment of GERD includes recommendations for the management of Barrett's esophagus as well, noted C. Daniel Smith, MD, immediate Past President of SAGES, and Professor of Surgery and Chair of the Department of Surgery at Mayo Clinic in Jacksonville. Barrett's is common in our practice and is the best known risk factor for the development of esophageal adenocarcinoma. We incorporate radiofrequency ablation in our esophageal program at Mayo Clinic, along with anti-reflux surgery, as an early intervention to avert cancer development.
The SAGES practice guideline is the first set of official recommendations from a professional society which have included the most recently published clinical trial outcomes related to the use of endoscopic RFA for treating Barrett's esophagus, commented David S. Utley, M.D., chief medical officer for BARRX Medical. We are pleased that the SAGES guideline has provided the recommendation that endoscopic RFA has clinical utility and should be offered as an option for patients with non-dysplastic and dysplastic Barrett's esophagus based on the quality of the clinical evidence. Verification, by SAGES, that RFA is a medically necessary option for patients with Barrett's is important as physicians, patients and payers consider this endoscopic treatment.
About BARRX Medical, Inc.
BARRX Medical, Inc. develops endoscopic treatment solutions for Barrett's esophagus and other chronic gastroenterological diseases. Barrett's 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 provide a uniform and controlled ablation effect, which removes diseased tissue and allows re-growth of normal cells.
A multi-center randomized, sham-controlled study, published in the New England Journal of Medicine in 2009, 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. In another study (AIM-II) published in Gastrointestinal Endoscopy, 98.4 percent 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 50,000 procedures have been performed in over 400 hospitals around the world. Based in Sunnyvale, Calif., BARRX Medical, Inc. was founded in 2000 and is privately-held. Additional information is available at http://www.barrx.com.
About The Society for American Gastrointestinal Endoscopic Surgeons (SAGES)
SAGES was founded in 1981 to support academic, clinical and research achievement in gastrointestinal endoscopic surgery (www.sages.org). SAGES has more than 6,000 physician members from the U.S. and 50+ other countries. The society has a representative on the American College of Surgeons Board of Governors, is a nominating member of the American Board of Surgery, and holds a seat in the AMA House of Delegates. SAGES established the first endoscopic and laparoscopic standards of training and practice for surgeons, initiated the Framework for Post Residency Education and Training in Endoscopic Surgery, and operates the pre-eminent Annual Congress in Endoscopic Surgery.
SOURCE: BARRX Medical Inc.