LAWRENCE, Mass., Dec. 22, 2014 /PRNewswire/ -- NxStage Medical,
Inc. (NASDAQ: 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.
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.
About the NxStage System One
The NxStage System One is the first and only portable hemodialysis
machine cleared specifically by the FDA for home hemodialysis and
home nocturnal hemodialysis. Its simplicity and revolutionary size
(just over a foot tall) are intended to allow convenient use in
patients' homes and give patients the freedom to travel with their
therapy. When combined with the NxStage Pureflow SL Dialysis
Preparation System, patients are able to further simplify, using
ordinary tap water to create dialysis fluid. Unlike conventional
hemodialysis systems, the System One requires no special
infrastructure to operate. Under the guidance of their physician,
patients can use the NxStage System One, with their trained
partners, where, how and when it best meets their needs, including
while they are sleeping - at home or on vacation and at a medically
appropriate treatment frequency. The System One is also used
to provide a range of flexible therapy options in more traditional
care settings such as hospitals and dialysis centers. Its safety
and efficacy have been demonstrated by experience with more than 10
million treatments with thousands of patients around the world.
http://www.nxstage.com/.
About NxStage Medical
NxStage Medical,
Inc. (Nasdaq: NXTM) is a medical device company, headquartered
in Lawrence, Massachusetts,
USA, that develops, manufactures and markets innovative
products for the treatment of ESRD and acute kidney failure. For
more information on NxStage and its products, please visit the
Company's website at www.nxstage.com.
Forward-Looking Statements
This release contains
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements contained
in this release that are not clearly historical in nature are
forward-looking, and the words "anticipate," "believe," "expect,"
"estimate," "plan," and similar expressions are generally intended
to identify forward-looking statements. Actual results may differ
materially from those indicated by these forward-looking statements
as a result of various important factors including those that are
discussed in NxStage's filings with the Securities and
Exchange Commission, including the Quarterly Report on Form 10-Q
for the quarter ended September 30, 2014. NxStage is under no
obligation to (and expressly disclaims any such obligation to)
update or alter its forward-looking statements, whether as a result
of new information, future events or otherwise.
Kristen K. Sheppard,
Esq.
VP, Investor Relations
ksheppard@nxstage.com
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SOURCE NxStage Medical, Inc.