LAWRENCE, Mass., March 16, 2015 /PRNewswire/ -- NxStage
Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of
dialysis products, today announced a late breaking abstract, "Home
Nocturnal Hemodialysis with Low Dialysate Volume: A Cross-Over
Study," outlining favorable outcomes for more frequent home
hemodialysis patients who transitioned to home nocturnal
hemodialysis with the NxStage® System One™. The National Kidney
Foundation accepted the abstract for poster presentation during its
2015 Spring Clinical Meeting in Dallas,
Texas.
Results from this study, conducted by nephrologists Brigitte Schiller, M.D. and Brent W. Miller, M.D., supported the Food and
Drug Administration's (FDA) recent clearance of the NxStage System
One to perform therapy overnight while patients are at home
sleeping, known commonly as nocturnal therapy. The Company's System
One is the first and only hemodialysis machine cleared by the FDA
for this indication.
"This study demonstrates that at-home, overnight hemodialysis is
both safe and effective for ESRD patients, and can help them live a
full life," said Brigitte Schiller,
M.D., Chief Medical Officer of Satellite Healthcare and Principal
Investigator of NxStage's home nocturnal hemodialysis trial. "Now
that the FDA has cleared the NxStage System One for nocturnal
therapy, I am even more committed to furthering the conversation on
nocturnal therapy and the incredible benefits it can offer to our
patients' health and quality of life."
This poster presentation will take place on Thursday, March 26, 2015 from 6:00 -7:30pm at the Gaylord Texan, and will
remain on display through Saturday, March
28, 2015.
Despite the health benefits that home hemodialysis may
provide to those with chronic kidney disease, this form of therapy
is not for everyone. The reported benefits of home hemodialysis may
not be experienced by all patients. The risks associated with
hemodialysis treatments in any environment include, but are not
limited to, high blood pressure, fluid overload, low blood
pressure, heart-related issues, and vascular access complications.
The medical devices used in hemodialysis therapies may add
additional risks including air entering the bloodstream and blood
loss due to clotting or accidental disconnection of the blood
tubing set. Certain risks are unique to the home. Treatments at
home are done without the presence of medical personnel and on-site
technical support. Patients and their partners must be trained on
what to do and how to get medical or technical help if
needed.
Additional Risks Associated with Nocturnal Home Hemodialysis
Therapy
The NxStage System One may be used at night while
the patient and care partner are sleeping. Certain risks associated
with hemodialysis treatment are increased when performing nocturnal
therapy due to the length of treatment time and because therapy is
performed while the patient and care partner are sleeping. These
risks include, but are not limited to, blood access disconnects and
blood loss during sleep, blood clotting due to slower blood flow or
increased treatment time or both, and delayed response to alarms
when waking from sleep. Ancillary anticoagulant infusion pumps and
fluid leak detection devices may be used to decrease certain risks
for home hemodialysis treatments performed at any time, but NxStage
requires the use of fluid leak detectors to identify leaks from the
vascular access, Cycler and Cartridge when performing nocturnal
therapy with 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 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 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, 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. 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 Annual Report on Form 10-K for the year
ended December 31, 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.
Media contact:
Kristen K. Sheppard, Esq.
ksheppard@nxstage.com
Tel: (978) 332-5923
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SOURCE NxStage Medical Inc.