LAWRENCE, Mass., Sept. 16, 2014 /PRNewswire/ -- NxStage® Medical,
Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis
products, today announced its single needle technology, OneSite™,
has received FDA clearance.
The OneSite employs a unique dual lumen needle design offered in
both a sharp version with MasterGuard® and a buttonhole version
with SteriPick® allowing the dialysis patient to have only one
needle inserted per dialysis treatment instead of two. The
combination of single site and buttonhole access is designed to
provide patient comfort during needle insertion and dialysis
treatment, as well as preservation of the patient's vascular
access. The dual lumen design also enhances patient safety
during treatment by having the machine alarm and shutdown upon
access dislodgement, reducing the risk of undetected Venous Needle
Dislodgement (VND) in the use of a two needle treatment.
"FDA clearance for OneSite is another significant milestone that
illustrates the success of our innovation strategy. It represents a
meaningful step forward in advancing the care of dialysis patients
and will enhance the safety for our home dialysis patients," said
Joseph E. Turk, President, NxStage
Medical, Inc. "Building on our breadth of technology and expertise
in fistula needles, we're bringing to market an elegant single
needle solution that does not have the complexity and complications
of other common approaches."
About the NxStage System One
The NxStage System
One is the first and only truly portable hemodialysis system
cleared for home use by the U.S. Food & Drug
Administration (FDA). 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 - at home
or on vacation and at a medically appropriate treatment
frequency. http://www.nxstage.com/.
About NxStage Medical NxStage Medical,
Inc.
NxStage 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 June 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.
Media contact:
Kristen K. Sheppard, Esq.
VP of Investor Relations
ksheppard@nxstage.com
Logo -
http://photos.prnewswire.com/prnh/20110503/MM94799LOGO
SOURCE NxStage Medical, Inc.