Barrx Medical, a developer of endoscopy medical devices, has received 510(k) clearance from the FDA to market its Halo90 Ablation Catheter for the treatment of radiation proctitis (RP) and gastric antral vascular ectasia (GAVE).
Barrx Medical’s 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.
The Halo90 catheter offers clinicians a 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 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.
Both Halo systems are cleared by the FDA for use in the US 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, California, Barrx Medical is a privately-held company which develops treatment solutions for Barrett’s esophagus and other chronic gastroenterological diseases. 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.