LAWRENCE, Mass., Aug. 28, 2017 /PRNewswire/ -- NxStage
Medical, Inc. (Nasdaq: NXTM), a leading medical
technology company focused on advancing renal care, today announced
that the U.S. Food and Drug Administration (FDA) has cleared its
System One for solo home hemodialysis, without a care partner,
during waking hours.
Since receiving its first clearance for home hemodialysis from
the FDA in 2005 and the first and only home nocturnal hemodialysis
clearance in 2014, the NxStage System One has provided over 14
million treatments to thousands of patients in their homes around
the world, during the day and at night. However, certain
patients have not had access to this therapy option due to the fact
that the System One's indication has required that a care partner
be present when a patient performs home hemodialysis. This new
expanded indication provides both new and existing System One
patients, trained to perform solo home hemodialysis, the freedom to
dialyze at home without a care partner during waking
hours.
"Patients have been asking for an FDA-cleared solo option for
years," stated Dr. Allan Collins,
Chief Medical Officer, NxStage. "Many patients have been turned
away from home hemodialysis simply because they did not have a care
partner. The ability to train and treat solo provides a
broader patient base with access to the clinical and quality of
life benefits associated with home hemodialysis."
"We are thrilled with this milestone achievement," said
Todd Snell, SVP of QA, Regulatory
& Clinical Affairs, NxStage. "Our interaction with the FDA
first began at a patient preference workshop followed by regular
dialogue throughout the pre-submission and submission processes.
The solo home hemodialysis clearance makes NxStage the first
company to formally conduct a patient preference study leading to a
label expansion."
"With much credit to our decade long history in the home, we
continue to do amazing things for dialysis patients," said
Joe Turk, President, NxStage. "As a
company, we are incredibly passionate about providing patients with
as much freedom and flexibility as possible to do their dialysis
therapy when they want and where they want, day or night. This
expanded indication for solo therapy is another significant step
forward for patients."
NxStage will be working with its customers and partners to
implement additional patient training for this new indication later
this year and into 2018. Interested patients should talk to their
nephrologist and care teams to fully understand both the risks and
benefits of solo therapy to determine if solo home hemodialysis is
right for them.
A trained and qualified patient may dialyze alone, without a
care partner present (solo home hemodialysis), provided the patient
and physician agree that solo home hemodialysis is appropriate.
Certain risks associated with hemodialysis treatment are increased
when performing solo home hemodialysis because no one is present to
help the patient respond to health emergencies. If patients
experience needles coming out, blood loss, or very low blood
pressure during solo home hemodialysis, they may lose consciousness
or become physically unable to correct the health emergency.
Losing consciousness or otherwise becoming impaired during any
health emergency while alone could result in significant injury or
death. Additional ancillary devices and training are required when
performing solo home hemodialysis. Patients should consult with
their physician to understand the risks and responsibilities
associated with solo home hemodialysis using the NxStage System
One.
About the NxStage System One
The NxStage System One is
the first and only truly portable hemodialysis system cleared
specifically by the FDA for home hemodialysis, home
nocturnal hemodialysis and solo home 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 on demand. 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 (or for patients prescribed to
receive solo dialysis, alone), 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. In
addition, NxStage's Nx2me Connected Health platform collects
important NxStage System One and patient information for
flexible viewing, monitoring and reporting that may improve patient
management and patient retention, as well as simplify alternative
site care. www.nxstage.com.
About NxStage Medical
NxStage Medical, Inc.
(Nasdaq: NXTM) is a leading medical technology company,
headquartered in Lawrence, Massachusetts, USA, that develops,
manufactures and markets innovative products for the treatment of
end-stage renal disease (ESRD) and acute kidney failure. NxStage
also has established a small number of dialysis clinics committed
to the development of innovative care delivery models for patients
with ESRD. For more information on NxStage and its products and
services, please visit the Company's websites
at www.nxstage.com and www.nxstagekidneycare.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 its Quarterly Report on Form 10-Q for the
quarter ended June 30, 2017. 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.
Media contact:
Kristen K. Sheppard, Esq.
ksheppard@nxstage.com
+1-978-332-5923
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SOURCE NxStage Medical, Inc.