Fresenius Renal Therapies Announces the Introduction of Next Generation Sentinel Technology to Support Fluid Management Challenges in the End Stage Renal Disease Community

WALTHAM, Mass.–(BUSINESS WIRE)–Fresenius Renal Therapies, a division of Fresenius Medical Care North
America (FMCNA), the leading provider of products and services for the
chronic kidney disease patient, announced today the introduction of its
latest technological enhancement in the Crit-Line® technology product
line, the CLiC™ device.
The CLiC device non-invasively measures hematocrit, oxygen saturation
and percent change in intravascular blood volume during a patient’s
hemodialysis (HD) treatment. As an integrated feature in the 2008T
hemodialysis machine, the organization’s flagship HD delivery system,
the healthcare professional has immediate, real-time access to a
patient’s hematocrit, percent change in blood volume and oxygen
saturation data, as well as essential dialysis treatment information
needed to make informed intradialytic adjustments.
Fluid overload is a common and serious problem that can lead to severe
complications in dialysis patients and is a major cause of reported
hospitalizations in this population. Bringing dialysis patients’ fluid
overload under control has been a central focus of clinicians and policy
makers for many years.
“We have been looking forward to the release of CLiC technology,” said
Mark Costanzo, President, Renal Therapies Group. “Fluid overload in
dialysis patients is an important issue that needs to be addressed. I’m
proud to support the introduction of a technological breakthrough that
will allow nephrologists to have access to important data and make
informed decisions that will directly impact the health and well-being
of this chronically-ill population. Fresenius Renal Therapies is
dedicated to working with nephrologists and dialysis clinicians in a
continued effort to improve patient outcomes and overall quality of
life.”
The CLiC device is designed to allow the health care professional to
remove the maximum amount of fluid from the hemodialysis patient while
preventing the common symptoms of dialysis such as nausea, cramping and
vomiting, thus providing a more effective treatment.
“The CLiC device represents a significant step forward in the evolution
of volume management,” said Frank Maddux, MD, Chief Medical Officer of
FMCNA. “By assisting clinical staff in managing hemodialysis patients’
complex fluid and intravascular volume conditions, the CLiC will be a
valuable tool for clinicians. Moreover, with the integration of the CLiC
device into the 2008T machine, clinical staff can more quickly recognize
a patient’s risk for low blood pressure during hemodialysis resulting
from certain ultrafiltration and intravascular blood volume
characteristics. Once the CLiC device alerts staff, they can pause
ultrafiltration until the clinicians can assess the situation of their
patient. This industry-leading device is a significant step forward in
improving patients’ quality of life.”
For customers utilizing other 2008® series machines, the organization
introduced, today, the Crit-Line® IV monitor, a stand-alone device
providing access to patient profile information, including hematocrit,
oxygen and percent change in intravascular blood volume during treatment.
About Fresenius Medical Care North America
Fresenius Medical Care North America 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, outpatient cardiac and vascular labs, and urgent
care centers, as well as the country’s largest practice of hospitalist
and post-acute providers, Fresenius Medical Care 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 www.freseniusmedicalcare.us.
For information about Crit-Line Technology visit www.fmcna-crit-line.com.
Indications for Use: The Crit-Line IV monitor is used to
non-invasively measure hematocrit, oxygen saturation and percent change
in blood volume. The sensor clip measures hematocrit, percent change in
blood volume and oxygen saturation in real time for application in the
treatment of dialysis patients with the intended purpose of providing 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, intervenes (i.e. increases
or decreases the rate at which fluid is removed from the blood) in order
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 Crit-Line blood chamber is a
sterile, single use, disposable, optical cuvette designed for use with
the Crit-Line sensor clip during acute and chronic hemodialysis therapy
to non-invasively measure hematocrit, percent change in blood volume and
oxygen saturation. The blood chamber is connected between the arterial
bloodline and the dialyzer within the extracorporeal circuit during the
hemodialysis treatment.
The CLiC device is used with the 2008T hemodialysis machine to
non-invasively measure hematocrit, oxygen saturation and percent change
in blood volume. The CLiC device measures hematocrit, percent change in
blood volume and oxygen saturation in real time for application in the
treatment of dialysis patients with the intended purpose of providing 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, intervenes (i.e., increases
or decreases the rate at which fluid is removed from the blood) in order
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 CLiC blood chamber is a
sterile, single use, disposable, optical cuvette designed for use with
the CLiC monitor’s sensor clip during acute and chronic hemodialysis
therapy to non-invasively measure hematocrit, percent change in blood
volume and oxygen saturation. The blood chamber is connected between the
arterial bloodline and the dialyzer within the extracorporeal circuit
during the hemodialysis treatment. The 2008T hemodialysis machine is
indicated for acute and chronic dialysis therapy.
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.