FDA Provides 510k Clearance for BARRX Medical's HALO90 Ablation Catheter for the Treatment of Radiation Proctitis and Gastric Antral Vascular Ecta... ( ...)

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FDA Provides 510k Clearance for BARRX Medical's HALO90 Ablation Catheter for the Treatment of Radiation Proctitis and Gastric Antral Vascular Ectasia (GAVE)

Date:3/3/2010

SUNNYVALE, Calif., March 3 /PRNewswire/ -- 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
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