U.S. Launch Expands Kidney Replacement Therapy Options With Integrated Anticoagulation

Critically ill patients with acute kidney injury often require continuous kidney replacement therapy in intensive care units. During these extracorporeal treatments, careful anticoagulation management helps reduce filter clotting while maintaining protocol-defined parameters. To support this balance, a newly launched system integrates regional citrate anticoagulation into continuous kidney replacement therapy for on-label use in the United States.

Fresenius Medical Care announced the U.S. launch of its multiFiltratePRO System on October 21, 2026, for critically ill patients with acute kidney injury. The system supports hospital intensive care teams delivering continuous kidney replacement therapy (CKRT), also known as continuous renal replacement therapy (CRRT).

To help teams minimize clotting during CKRT, an important factor in delivering effective treatment, multiFiltratePRO incorporates integrated citrate and calcium pumps that work with the Ci-Ca Protocol to provide regional citrate anticoagulation without separate external infusion pumps. Citrate and calcium infusion rates automatically adjust as blood and effluent flow rates change, helping clinicians maintain protocol-defined ratios throughout therapy.

The launch follows the U.S. Food and Drug Administration’s (FDA) October 19, 2026, clearance of multiFiltratePRO and approval of its dedicated solutions, Cienby (sodium citrate solution) and Calrezdy (calcium chloride solution). Together, they represent the country’s first CKRT system and solutions package for on-label regional citrate anticoagulation using the Ci-Ca Protocol.

Cienby is indicated for regional citrate anticoagulation during continuous venovenous hemodialysis (CVVHD) or continuous venovenous hemodiafiltration (CVVHDF) in adults and pediatric patigintroents weighing at least 40 kg. Calrezdy provides calcium substitution in the same settings and populations. The multiFiltratePRO System is indicated for physician-prescribed CRRT, with or without integrated regional anticoagulation, in patients weighing at least 40 kg who have acute renal failure with or without fluid overload.

A multicenter randomized controlled trial cited in the announcement reported that, among critically ill patients with acute kidney injury receiving CKRT, regional citrate anticoagulation increased filter life span compared with systemic heparin; the study was underpowered to draw definitive conclusions regarding mortality. multiFiltratePRO is being showcased at ASN Kidney Week 2026 in Denver at Booth 571. The U.S. rollout will begin in a controlled launch and move quickly to full availability.

“Fresenius Medical Care has a long history of bringing innovative kidney care solutions to patients around the world and making them available in new markets where they can have an even greater impact. The introduction of multiFiltratePRO enabled with the Ci-Ca Protocol is another example of that commitment. As the first FDA-cleared continuous kidney replacement therapy (CKRT) system, designed to support regional citrate anticoagulation (RCA) during CVVHD and CVVHDF on-label use in the United States, it expands the options available to critical care teams while reinforcing our leadership in advancing kidney care innovation,” said Joe Turk, Chief Executive Officer of Care Enablement at Fresenius Medical Care.

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