NxStage from Fresenius Medical Care Launches Speedswap® for Critical Care Dialysis

New Cartridge Aims to Reduce Therapy Downtime, Ease Workloads, and Lower Costs of Hemodialysis Treatment in Acute Care Settings

WALTHAM, Mass., Aug. 25, 2022 /PRNewswire/ -- Fresenius Medical Care North America's (FMCNA) Renal Therapies Group today announced the availability of Speedswap^®, a new option for the NxStage^® System One^™ with NxView^™ that enables the changing of a flow-compromised dialysis filter without replacing the entire cartridge. The new Speedswap system is designed to help reduce therapy downtime,¹ ease nursing workloads,¹ and lower treatment costs² in acute care settings.

Clogging or clotting of the dialysis circuit is a common occurrence associated with continuous kidney replacement therapy (CKRT) in critical care settings, which can lead to therapy downtime.³ Speedswap allows a flow-compromised NxStage filter to be replaced without replacing the cartridge through the use of a pre-attached, yet detachable, filter.

"This introduction of Speedswap aims to both improve the quality of dialysis treatment in the critical care setting and make our technology even easier to use by the care team," said Joe Turk, President of the Renal Therapies Group at Fresenius Medical Care North America. "This product is another example of how we are always working to introduce innovations that improve our NxStage System One and ensure it remains the first and best choice of all hospitals for continuous therapy."

The innovative system brings to the market two products to be used with the NxStage System One with NxView -- Cartridge Express with Speedswap and Speedswap Express Kit.

Some of the features of the Speedswap cartridge system include:

• Shipping connectors designed to maintain the sterility and integrity of valves during storage and the shipping process.
• Valves that enable the user to disconnect the pre-attached filter. The valves are designed to stop the flow of fluid when disconnected and allow fluid to flow when connected.
• A line restrictor that is designed to allow for pressure adjustment within the venous and arterial lines, as well as to allow for connections to alternate sources of access.
• Safe2 Rotator Connector that features a spin-lock designed to prevent accidental disconnect and improve handling for greater flexibility and durability.
• Pressure Oscillating Diaphragm (POD) Technology that is created to eliminate the blood-air interface and may reduce the risk of filter clotting and related therapy interruptions.
• Needleless valves designed to minimize the occurrence of air in the circuit.

"The simplified filter exchange should help make our life-sustaining therapy even easier to provide in an often busy critical care setting," said Dr. Mike Anger, Chief Medical Officer for FMCNA's Renal Therapies Group. "We also hope to improve patient outcomes by reducing the time necessary to change dialysis filters which should minimize interruption to continuous kidney replacement therapy."

The NxStage System One with NxView is used by leading U.S. hospitals including the majority of the top renal care hospitals as ranked by US News & World Report.⁴ With a uniquely designed volumetric fluid balancing system, fluid accuracy is achieved without the need for scales. Simple, intuitive controls are designed to ensure ease of use and simplify user experience, while scale-based alarms are completely eliminated, reducing staff workload.

Effluent flows to an open drain line, eliminating interruptions in therapy due to emptying waste bags, and the system eliminates the need for cumbersome equipment and water treatment systems.

For more information about Speedswap, please visit: https://fmcna.com/products/critical-care/speedswap.

Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician.

Read the Instructions for Use for safe and proper use of this device. For a complete description of hazards, contraindications, side effects, and precautions, see full package labeling at fmcna.com.

Kidney replacement therapy, as with any medical therapy, is not without risks. The decision of which therapy to use should be made by the physician, based on previous experience and on the individual facts and circumstances of the patient. There is no literature demonstrating one therapy is clinically better than another.⁵

NxView is contraindicated as the sole method of monitoring a patient during treatment.¹

The Speedswap cartridge can only be used with the following software versions and user guide:

• NxView Software 3.1 or higher
• System One Cycler Software 4.14 or higher
• NxStage System One User Guide NC4921 Rev. J or higher

1. NxStage System One Critical Care User Guide. NC4921 Rev. M. 2022; Data on file, 08/2021; Instructions for Use CAR-535/SSK-535. NC45-0926. Rev. F. 2022.
2. Data on file. January 2022.
3. Joannidis M, Oudemans-van Straaten HM. Clinical Review: Patency of the Circuit in Continuous Renal Replacement Therapy. Crit Care 2007;11(4):218.
4. Harder, B. America's Best Hospitals: the 2021-22 Honor Role and Overview. https://health.usnews.com/best-hospitals/hospital-ratings/kidney-failure, accessed 7/21/2022.
5. Nash DM, Przech S, Wald R, O'Reilly D, "Systematic review and meta-analysis of renal replacement therapy modalities for acute kidney injury in the intensive care unit," Journal of Critical Care, 2017. 41:138–144.

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
[email protected]
+1 (940) 297-5678

©2022 Fresenius Medical Care. All Rights Reserved. Fresenius Medical Care, the triangle logo, NxStage, Speedswap, NxView, and System One are trademarks of Fresenius Medical Care Holdings, Inc., or its affiliated companies. All other trademarks are the property of their respective owners.

SOURCE Fresenius Medical Care Holdings, Inc.