FDA Provides 510k Clearance for BARRX Medical's HALO90 Ablation Catheter for the Treatment of Radiation Proctitis and Gastric Antral Vascular Ectasia (GAVE)
SUNNYVALE, Calif., March 3 BARRX Medical, Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its HALO90 Ablation Catheter for the treatment of Radiation Proctitis (RP) and Gastric Antral Vascular Ectasia (GAVE). Both conditions are diseases of the gastrointestinal tract associated with chronic bleeding and the need for blood transfusions. The HALO90 catheter is used in conjunction with the HALOFLEX and HALO90 Energy Generators during endoscopic procedures to control bleeding in the gastrointestinal tract through the coagulation of affected tissue. The new 510(k) release is an expansion of the HALO90 catheter's previous indication for use, which includes the treatment of a precancerous condition of the esophagus, known as Barrett's esophagus.
Bleeding associated with radiation proctitis is a common side effect of pelvic radiation therapy. Affecting approximately 5% of patients treated for cancers of the prostate, ovaries and cervix, chronic bleeding from radiation proctitis may result in the need for transfusions, multiple procedures to control bleeding, and impairment in patient quality of life.
Gastric antral vascular ectasia, also known as "watermelon stomach" due to associated striping of the stomach lining, is a condition of the lower stomach in which the blood vessels that make up the stomach lining become fragile and prone to rupture. While the cause of GAVE is not well understood, it is often associated with systemic diseases such as liver cirrhosis or autoimmune disorders. Patients with GAVE typically suffer from chronic anemia due to blood loss.
The HALO90 catheter offers clinicians a novel, non-surgical, outpatient therapy for control of bleeding in their patients with GAVE and RP, many of whom have failed prior endoscopic interventions and have few remaining options. As evidenced by its extensively studied use for coagulating tissue in the esophagus, the HALO90 catheter treats a broad area of diseased or bleeding tissue rapidly and achieves a controlled depth of ablation, both of which are important factors in the treatment of these conditions.
About BARRX Medical, Inc.
BARRX Medical, Inc. develops 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, 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 350 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.
SOURCE BARRX Medical, Inc.
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