Practice Guidelines Confirm Utility of Endoscopic Radiofrequency Ablation (RFA) for the Treatment of Barrett's EsophagusBy Barrx Medical Inc., PRNE
Wednesday, March 9, 2011
SUNNYVALE, California, March 10, 2011 - 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
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
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
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.
Media, Kevin Knight, +1-972-385-9384, cell, +1-214-732-9392, KKnightpr at gmail.com, for BARRX Medical, Inc.; or Gregory A. Barrett of BARRX Medical, Inc., +1-408-328-7308, gbarrett at barrx.com
Tags: Barrx Medical Inc., california, March 10, Sunnyvale