CombiSet SMARTECH™ Offers Innovative New
Design and Simplifies Use
WALTHAM,
Mass., July 27, 2022 /PRNewswire/
-- Fresenius Medical Care North America's (FMCNA) Renal
Therapies Group today announced the availability of the CombiSet
SMARTECHTM, the first available single-use bloodline
with an integrated Crit-Line® blood chamber (CLiC™) that
simplifies use by reducing the number of manual connections
required. The CLICTM Blood Chamber is built into the
bloodline itself and is designed to provide optimal performance
with the 2008® series hemodialysis machines.
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Crit-Line technology is designed to continuously
monitor the percent change in blood volume, plasma
refill, oxygen saturation and other key parameters during the
hemodialysis treatment. This data can guide the
clinician to intervene, if necessary, by adjusting the
ultrafiltration rates to provide a more effective dialysis
treatment. Fluid overload, or hypervolemia, is a common
complication of kidney disease, particularly in patients with
end-stage renal disease (ESRD) on hemodialysis. It is often
associated with adverse outcomes including hypertension,
exacerbation of congestive heart failure (CHF), and increased risk
of death.1
"By combining these two components into one bloodline, we are
simplifying the set-up process which will hopefully encourage
increased use of Crit-Line technology," said Dr. Mike Anger, SVP and Chief Medical Officer for
FMCNA's Renal Therapies Group. "This new bloodline is designed to
make fluid management even easier, providing insights that can help
better manage the fluid status of dialysis patients."
The CombiSet SMARTECH offers key advantages when providing
hemodialysis to patients in outpatient or acute settings:
- Increased Ease of Use: Less product to manage at point
of care; less inventory to maintain.
- Fewer Connections: The new integrated bloodline line has
only one connection, eliminating the need for additional components
and simplifying the connection process.
"This introduction of this new bloodline is part of our
commitment to bring innovations to market that improve patient
care, making the dialysis process simpler and safer for our
patients," said Pat McCarthy, SVP of
FMCNA's Renal Therapies Group. "This new integrated system is a
step forward within our already trusted and reliable bloodline
product offerings."
For more information about CombiSet SMARTECH, along with the
benefits and features of the Crit-Line technology, visit
https://fmcna.com/combiset-smartech.
About Fresenius Medical Care North America
Fresenius
Medical Care North America (FMCNA) is the premier healthcare
company focused on providing the highest quality care to people
with renal and other chronic conditions. Through its
industry-leading network of dialysis facilities and outpatient
cardiac and vascular labs, Fresenius Medical Care North America
provides coordinated healthcare services at pivotal care points for
hundreds of thousands of chronically ill customers throughout the
continent. As the world's largest fully integrated renal company,
it offers specialty pharmacy and laboratory services, and
manufactures and distributes the most comprehensive line of
dialysis equipment, disposable products, and renal pharmaceuticals.
For more information, visit the FMCNA website
at https://fmcna.com/.
Disclaimer
This release contains forward-looking
statements that are subject to various risks and uncertainties.
Actual results could differ materially from those described in
these forward-looking statements due to certain factors, including
changes in business, economic and competitive conditions,
regulatory reforms, foreign exchange rate fluctuations,
uncertainties in litigation or investigative proceedings, and the
availability of financing. These and other risks and uncertainties
are detailed in Fresenius Medical Care AG & Co. KGaA's reports
filed with the U.S. Securities and Exchange Commission. Fresenius
Medical Care AG & Co. KGaA does not undertake any
responsibility to update the forward-looking statements in this
release.
Media Contact:
Fresenius Medical Care North America
Scott Sayres
Corporate Communications
scott.sayres@freseniusmedicalcare.com
(940) 297-5678
1 Arneson TJ, et al., Hospital treatment for
fluid overload in the Medicare hemodialysis
population. Clin J Am Soc Nephrol.
2010;5(6):1054-1063.
Indication for Use:
Crit-Line Technology is designed
to non-invasively measure hematocrit, oxygen saturation and percent
change in blood volume. The technology employs a sensor clip which
emits multiple wavelengths of light to trans-illuminate the blood
in the Crit-Line blood chamber. The differences in light
absorption between blood constituents allow for the identification
and measurement of the hematocrit. The measurement of hematocrit,
percent change in blood volume and oxygen saturation in real-time
during hemodialysis is intended to provide a more effective
treatment for both the dialysis patient and the clinician. Based on
the data that the monitor provides, the clinician/nurse, under
physician direction, can intervene (i.e., by increasing or
decreasing the rate at which fluid is removed from the blood) to
remove the maximum amount of fluid from the dialysis patient
without the patient experiencing the common complications of
dialysis which include nausea, cramping and vomiting. The
technology is available as a stand-alone device (Crit-Line IV
Monitor) or as an optional module on the 2008T hemodialysis machine
series (CLiC™ device).
CombiSet SMARTECH Hemodialysis Blood Tubing Set
- The Blood Tubing Set is a sterile, single use, disposable
indicated for use with a prescribed hemodialyzer. The suitability
of a particular bloodline/hemodialyzer configuration is the
responsibility of the physician.
- The Blood Tubing Set is intended for acute and chronic
hemodialysis therapy.
- The Blood Tubing Set is intended to be used with Fresenius
Medical Care 2008® Series K, K2, and T Hemodialysis Machines
equipped with Crit-Line hardware.
- The Crit-Line Blood Chamber is an optical cuvette designed for
use with the Crit-Line monitor's sensor clip during acute and
chronic hemodialysis therapy to noninvasively measure hematocrit,
percent change in blood volume, and oxygen saturation.
Caution: Federal (US) law restricts these devices to sale
by or on the order of a physician.
Note: Read the Instructions for Use for safe and
proper use of these devices. For a complete description of hazards,
contraindications, side effects and precautions, see full package
labeling at www.fmcna.com.
© 2021 Fresenius Medical Care. All Rights Reserved. Fresenius
Medical Care, the triangle logo, Fresenius Renal Technologies,
2008, Crit-Line CLiC, CombiSet, and
CombiSet SMARTECH are trademarks of Fresenius Medical Care
Holdings, Inc., or its affiliated companies. All other trademarks
are the property of their respective owners.
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SOURCE Fresenius Medical Care Holdings, Inc.