Fresenius Medical Care North America Introduces First Single-Use Integrated Bloodline to Support Fluid Management in Dialysis

CombiSet SMARTECH™ Offers Innovative New Design and Simplifies Use

WALTHAM, Mass. – July 27, 2022 – 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.

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.

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.