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FDA approves NxStage's System One for home nocturnal hemodialysis
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The U.S. Food and Drug Administration has cleared NxStage Medical Inc.'s System One to perform home nocturnal hemodialysis. NxStage's System One is the only hemodialysis machine cleared by the FDA for this indication.
A longer, overnight therapy also allows greatly expanded flexibility in dialysis dose and schedule, better enabling physicians to match the dialysis prescription to individual patient needs, NxStage said in a news release.
"For years, patients and physicians in the United States have been asking for an FDA-cleared home nocturnal hemodialysis option for the improved outcomes and quality of life the modality can deliver," said Brigitte Schiller, MD Chief Medical Officer of Satellite Healthcare and principal investigator of NxStage's home nocturnal hemodialysis trial. "I, along with my fellow investigators in this trailblazing trial, am pleased that we were able to demonstrate the NxStage System One can safely and effectively deliver this important treatment option."
NxStage said it is preparing for a full U.S. market launch in 2015. The System One is also CE-marked for home nocturnal hemodialysis in Europe.
"We are delighted with this milestone achievement, which we believe will open home hemodialysis therapy to new segments of patients, and improve patient care for ESRD patients by expanding therapeutic options and flexibility,"said Jeffrey Burbank, Founder and Chief Executive Officer of NxStage. "This 'first of its kind' clearance is the culmination of significant product innovation, ongoing collaboration with the FDA, a rigorous clinical trial and our experience in delivering over 10 million treatments with the System One around the world."