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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