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

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.

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