Bad Homburg, Germany, October 21, 2026
Fresenius Medical Care has announced the U.S. launch of its multiFiltratePRO System, an advanced kidney replacement therapy technology designed to support critically ill patients with acute kidney injury (AKI). The launch follows clearance from the U.S. Food and Drug Administration (FDA) for the system on October 19, 2026, alongside approval of its dedicated solutions, Cienby™ (sodium citrate solution) and Calrezdy™ (calcium chloride solution). The system is intended to expand treatment options for patients requiring continuous kidney replacement therapy (CKRT) in intensive care settings. AKI is a serious condition in which kidney function deteriorates, affecting the body’s ability to remove waste and maintain fluid and electrolyte balance. For critically ill patients, continuous treatment can provide ongoing kidney support while their clinical condition is managed. Fresenius Medical Care says multiFiltratePRO combines integrated technology with an automated treatment protocol to help intensive care teams manage complex procedures more efficiently. The launch also expands the company’s established kidney care technology portfolio into the U.S. market, bringing a treatment approach already used in other regions to American healthcare providers.
FDA Clearance Expands Continuous Kidney Therapy Options
The FDA clearance of multiFiltratePRO, together with the approval of Cienby and Calrezdy, enables a dedicated system-and-solutions package for regional citrate anticoagulation (RCA) using the company’s Ci-Ca Protocol. RCA helps prevent blood from clotting within the extracorporeal circuit during continuous kidney replacement therapy. Cienby is indicated as an anticoagulant during continuous venovenous hemodialysis (CVVHD) or continuous venovenous hemodiafiltration (CVVHDF), while Calrezdy provides calcium replacement during these procedures. The approved indications cover adults and pediatric patients weighing 40 kilograms or more. The multiFiltratePRO system is indicated for continuous renal replacement therapy, with or without integrated regional anticoagulation, in patients weighing at least 40 kilograms who have acute renal failure, with or without fluid overload. Treatment must be prescribed by a physician. According to Fresenius Medical Care, the system and dedicated solutions represent the first package available in the United States for on-label RCA using this protocol. The regulatory milestone provides hospitals with another option for managing patients who need continuous kidney support during critical illness. The products must be used according to their approved indications and prescribing information, with appropriate monitoring by trained clinical teams.
Integrated Ci-Ca Technology Supports ICU Teams
A central feature of multiFiltratePRO is its integrated citrate and calcium pump technology, which removes the need for separate external infusion pumps for these components. Through the Ci-Ca Protocol, citrate and calcium infusion rates automatically adjust in response to changes in blood and effluent flow, helping clinicians maintain protocol-defined ratios during treatment. This integration is designed to simplify workflow and support consistent delivery of regional citrate anticoagulation in intensive care units, where patients may require continuous observation and adjustments to therapy. Preventing clotting in the treatment circuit is important because circuit clotting can interrupt therapy and require filter replacement. A multicenter randomized controlled study published in JAMA reported that regional citrate anticoagulation, compared with systemic heparin anticoagulation, increased filter lifespan among critically ill patients receiving continuous kidney replacement therapy. However, that study was underpowered to draw definitive conclusions about mortality. The use of citrate also requires careful monitoring of calcium levels, electrolytes and acid-base balance. Hypocalcemia, hypercalcemia, hypernatremia, hypomagnesemia and metabolic disturbances are among the important risks described in the product safety information. Patients with impaired citrate metabolism, including some with liver impairment or shock, may require particular attention because citrate accumulation can occur. These safety considerations make trained staff, laboratory monitoring and adherence to prescribing information essential.
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U.S. Rollout Begins as Kidney Care Innovation Advances
Fresenius Medical Care plans to begin the U.S. launch through a controlled rollout, followed by broader availability. The company will also showcase multiFiltratePRO during ASN Kidney Week 2026 in Denver, Colorado, where healthcare professionals can learn about the system and its potential role in critical care. The launch follows the company’s introduction of other kidney care technologies in the United States and reflects its strategy of bringing established international treatment approaches to additional markets. By combining continuous renal replacement therapy with integrated regional citrate anticoagulation, multiFiltratePRO aims to give hospital teams another option for managing acute kidney injury in critically ill patients. Its clinical value will depend on appropriate patient selection, trained operation, careful monitoring and use within the FDA-cleared indication. The U.S. introduction is therefore a significant development in medical technology for renal care, expanding the available tools for intensive care teams while reinforcing the importance of safe, closely supervised treatment for patients with severe kidney dysfunction.
Source: Fresenius Medical Care press release
