LAWRENCE, Mass., March 25, 2015 /PRNewswire/ -- NxStage
Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of
dialysis products, today announced the presentation of four new
abstracts demonstrating clinical outcomes during the National
Kidney Foundation's Spring Clinical Meeting in Dallas, Texas. Three of the abstracts
highlight improved survival, reduced cardiovascular hospital
readmissions, and increased transplantation for daily home
hemodialysis (DHHD) patients using the NxStage® System One™ versus
other modalities. The fourth abstract details results from the
Company's groundbreaking study that led to the clearance of the
System One as the first and only hemodialysis machine cleared for
home nocturnal hemodialysis (home NHD).
The first three abstracts derive from work conducted by
Eric Weinhandl, MS, PhD
candidate and Dr. Allan Collins of
the Chronic Disease Research Group (CDRG), funded by NxStage. These
show:
- 29% lower risk of death for incident patients using DHHD vs.
patients receiving conventional in-center hemodialysis (IHD),
- 15% lower risk of 30-day readmission after hospitalization for
heart failure than peritoneal dialysis (PD) patients and 27%
lower than IHD patients, and
- 37% greater incidence of transplant for DHHD patients than PD
patients, and 22% greater than IHD patients.
The fourth abstract presented at the meeting, from a
NxStage-funded registration trial led by Dr. Brigitte Schiller of Satellite Healthcare and
Dr. Brent W. Miller of Washington University in Saint Louis, Missouri, details favorable
results of 58 ESRD patients receiving home NHD with the NxStage
System One. The study demonstrated results of increased clearance,
improved phosphorus control, and comparable safety and efficacy to
DHHD. The open-label, prospective, two-treatment, two period
crossover, non-inferiority study enrolled, trained, and
transitioned DHHD patients to home NHD, and subsequently treated
them for eight weeks on home NHD.
"These new data continue to highlight the benefits, safety, and
efficacy of daily home hemodialysis with respect to important, long
intractable challenges not fully addressed by conventional
dialysis. The complete alignment of randomized,
observational, and epidemiological studies with respect to daily
hemodialysis benefits is compelling," said Collins, Director of the
Chronic Disease Research Group and Senior Medical Advisor for
NxStage. "Moreover, showing that nocturnal hemodialysis may be
administered in the home with relative safety and efficacy to gain
the first-ever clearance in the U.S. for this indication represents
a major milestone in the treatment of kidney disease."
"NxStage has long been committed to product innovation and
quality clinical research to help improve the lives of patients
with kidney failure," said Joe Turk,
President of NxStage Medical. "We are delighted that these data
will be shared in these important clinical sessions, so that
awareness and understanding increase and more patients and their
families may ultimately gain access to this life-changing
therapy."
The posters, numbers 278, 279, 280, and 338, will be presented
on Thursday, March 26, 2015 from
6:00 - 7:30pm and remain on display
at the Gaylord Texan 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.