Practice Guidelines Confirm Utility of Endoscopic Radiofrequency Ablation (RFA) for the Treatment of Barrett's Esophagus

SUNNYVALE, Calif., March 10, 2011 /PRNewswire/ -- BARRX Medical, Inc., a leader in developing minimally invasive medical devices to remove precancerous tissue from the gastrointestinal tract, reported today that the American Gastroenterological Association (AGA) has issued the AGA Medical Position Statement on the Treatment of Barrett's Esophagus. The guideline recommends removal of precancerous cells in patients with confirmed high-grade Barrett's esophagus utilizing endoscopic eradication therapy, such as radiofrequency ablation (RFA) technology as delivered by the BARRX HALO Ablation System.

To provide the basis for the medical position statement, a technical review of the literature was conducted to explore a series of questions regarding management of Barrett's esophagus. The technical review was submitted to a medical position panel consisting of a diverse group of stakeholders, including gastroenterologists, a general surgeon, a pathologist, a health plan representative, and a consumer/patient advocate. The medical position statement was then created, which includes information affirming the utility of RFA therapy as a treatment option for eradication of Barrett's esophagus.

More specifically, the medical position statement recommends endoscopic eradication therapy – such as RFA – for patients with confirmed high-grade dysplasia (advanced precancerous cells) as opposed to watchful waiting or immediate esophagectomy. For patients with confirmed low-grade dysplasia (less advanced precancerous cells), endoscopic eradication therapy is recommended as a therapeutic option and should be discussed with patients as such.

Patients who present with non-dysplastic (early precancerous cells) Barrett's, the AGA states, "Although endoscopic eradication therapy is not suggested for the general population of patients with Barrett's esophagus in the absence of dysplasia, we suggest that RFA, with or without endoscopic mucosal resection (EMR), should be a therapeutic option for select individuals with nondysplastic Barrett's esophagus who are judged to be at increased risk for progression to high-grade dysplasia or cancer."  The AGA goes on to reinforce the importance of a "shared decision making where the treating physician and patient together consider whether endoscopic surveillance or eradication therapy is the preferred management option for each individual."

BARRX Medical President and CEO, Greg Barrett said, "We are extremely pleased the AGA Medical Position Statement confirms the utility of radiofrequency ablation for Barrett's patients with dysplasia and comments that high-risk Barrett's patients without dysplasia should also be considered for treatment. These guidelines validate what has been demonstrated in over 75,000 RFA procedures and 55 peer-reviewed published papers: Barrett's esophagus patients can be safely cured 90 to 100 percent of the time." Barrett added, "The AGA's position supports the collaborative work between our company and a rapidly growing number of physicians who wish to treat all forms of dysplastic Barrett's. The AGA Medical Position Statement is a rigorously constructed publication that will assist BARRX and treating physicians in addressing payer policies so that RFA procedures are uniformly recognized as medically necessary services."

The AGA's new opinion follows similar clinical practice guidelines published in 2010 by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) addressing the management of patients with gastroesophageal reflux disease and Barrett's esophagus.

Barrett's esophagus is a precancerous condition of the lining of the esophagus caused by gastroesophageal reflux disease (GERD). Left untreated, backward flow of stomach contents such as acid and bile into the esophagus can lead to injury and chronic inflammation of the esophagus lining. A proportion of GERD patients are thus at risk of developing Barrett's esophagus, which can lead to esophageal adenocarcinoma, a lethal cancer with a five-year survival rate of approximately 15%.

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 HALO90, HALO90 ULTRA and HALO360+ ablation catheters, driven by the HALOFLEX ablation system provide a uniform and controlled ablation effect, which removes diseased tissue and allows re-growth of normal cells.

Based in Sunnyvale, Calif., BARRX Medical, Inc. was founded in 2000 and is privately-held. Additional information is available at www.barrx.com.

SOURCE BARRX Medical, Inc.