xStage Receives FDA Clearance for Home Nocturnal Hemodialysis

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NxStage Medical, Inc.
NXTM
, a leading manufacturer of innovative dialysis products, announced today that the U.S. Food and Drug Administration (FDA) has cleared its System One™ to perform hemodialysis overnight while the patient is at home sleeping, known as home nocturnal hemodialysis. NxStage's® System One is the first and only hemodialysis machine cleared by the FDA for this indication. NxStage Medical, Inc. Home nocturnal hemodialysis is an important patient option associated with a number of lifestyle and clinical advantages. By doing therapy while sleeping, the patient frees up their day to pursue other activities therefore reducing the overall burden of therapy. 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. "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," stated Brigitte Schiller, M.D, 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." "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," stated 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." The Company is actively preparing for a full U.S. market launch in support of this expanded indication in 2015. The System One also is CE-marked for home nocturnal hemodialysis.
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