Fresenius Medical Care Launches Advanced Kidney Replacement Therapy in the U.S.

TL/DR –

Fresenius Medical Care has launched the multiFiltratePRO System in the US for patients with acute kidney injury. The system, which received FDA clearance on October 19, 2026, uses integrated technology to facilitate complex treatments for intensive care hospital teams. The launch marks another step in Fresenius Medical Care’s efforts to develop and implement advanced kidney therapies worldwide.


Fresenius Medical Care Launches Kidney Replacement System in the U.S.

The global leader in kidney disease products and services, Fresenius Medical Care, has announced the U.S. launch of multiFiltratePRO System for patients suffering from acute kidney injury (AKI). The advanced technology integrated in multiFiltratePRO simplifies the complex treatment process, eliminating the need for separate citrate and calcium pumps, and automatically adjusting to treatment conditions.

On October 19, 2026, the U.S. Food and Drug Administration (FDA) cleared the multiFiltratePRO System and approved Cienby™ and Calrezdy™, making it the first continuous kidney replacement therapy (CKRT) system with dedicated solutions available in the United States. The system supports intensive care teams treating critically ill patients with AKI, defined by kidney loss ability to filter waste from the blood.

This launch showcases Fresenius Medical Care’s capacity to identify, develop, and scale innovative therapies globally. The company recently introduced the 5008X™ CAREsystem in the U.S., bringing hemodiafiltration (HDF) – standard care in many parts of Europe and Asia-Pacific – to American patients. The introduction of multiFiltratePRO, enabled with the Ci-Ca Protocol, continues Fresenius’ tradition of bringing successful treatment approaches to U.S. healthcare providers and patients.

The multiFiltratePRO System features integrated citrate and calcium pumps working with the Ci-Ca protocol to deliver RCA without extra infusion pumps. Clinicians can maintain protocol-defined ratios throughout therapy as citrate and calcium infusion rates automatically adjust to changes in blood and effluent flow. A multicenter randomized controlled trial reported that among critically ill patients with AKI receiving CKRT, anticoagulation with regional citrate increased filter life span compared with systemic heparin anticoagulation.1

“As the first FDA-cleared CKRT system designed to support RCA during CVVHD and CVVHDF on-label use in the U.S., the introduction of multiFiltratePRO with the Ci-Ca Protocol exemplifies our commitment to advancing kidney care innovation,” said Joe Turk, Chief Executive Officer of Care Enablement at Fresenius Medical Care.

The multiFiltratePRO will be exhibited at ASN Kidney Week 2026 in Denver. Attendees can visit Booth 571 to see the system, interact with product experts, and learn more about its role in supporting patients with acute kidney injury.

The U.S. launch will begin as a controlled rollout and move quickly to full availability.

The multiFiltratePRO System is indicated for the following use: Continuous Renal Replacement Therapy (CRRT) with and without integrated regional anticoagulation for patients weighing 40 kilograms or more with acute renal failure with or without fluid overload. All treatments administered by the multiFiltratePRO System must be prescribed by a physician.

For more information about the company and its services, visit Fresenius Medical Care.

1 Zarbock A, et al. JAMA. 2020;324(16):1629-1639. doi:10.1001/jama.2020.18618

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