Fresenius Medical Care Brings Kidney Care Innovation to Critical Care Patients with U.S. Launch of multiFiltratePRO™
FDA clearance and dedicated solution approvals expand U.S. options for continuous kidney replacement therapy.
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Rhea-AI Summary
Fresenius Medical Care (FMS) launched its multiFiltratePRO System in the United States for critically ill patients with acute kidney injury. On October 19, 2026, the FDA cleared the system and approved its dedicated Cienby sodium citrate and Calrezdy calcium chloride solutions. The package supports regional citrate anticoagulation, which prevents clotting in the external blood circuit during continuous kidney replacement therapy.
The system is indicated for patients weighing 40 kilograms or more with acute renal failure, with or without fluid overload. Integrated citrate and calcium pumps automatically adjust infusion rates as treatment conditions change. The company plans a controlled U.S. rollout followed quickly by full availability.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointU.S. launch brings multiFiltratePRO into the American acute kidney injury treatment market.
- Moderate pointFDA clearance and solution approvals on October 19, 2026 enable on-label regional citrate anticoagulation.
- Minor point. Forward-looking: it has not happened yet and may not happen.Full U.S. availability is planned quickly after an initial controlled rollout.
Negative
- Minor pointSolution safety risks include calcium imbalances, metabolic disturbances, arrhythmias and, with Calrezdy, decreased blood pressure.
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Expands access to Fresenius Medical Care's globally established portfolio of advanced kidney replacement therapies in the
U.S . - FDA clearance of multiFiltratePRO and approval of dedicated solutions expand continuous kidney replacement therapy options for
U.S . patients requiring treatment for acute kidney injury - Integrated technology helps hospital intensive care teams deliver complex treatment simply and efficiently
BAD HOMBURG,
On October 19, 2026, the
The launch reflects Fresenius Medical Care's longstanding ability to identify, develop and scale innovative therapies across global markets. Most recently, the company introduced the 5008X™ CAREsystem in
The multiFiltratePRO System features integrated citrate and calcium pumps that work with the Ci-Ca protocol to deliver RCA without the need for separate external infusion pumps. With the Ci-Ca protocol, citrate and calcium infusion rates automatically adjust to changes in blood and effluent flow, helping clinicians maintain protocol-defined ratios throughout therapy. For ICU teams, minimizing clotting during CKRT is an important part of delivering effective treatment. A multicenter randomized controlled trial reported that among critically ill patients with AKI receiving CKRT, anticoagulation with regional citrate, compared with systemic heparin anticoagulation, increased filter life span. The study was underpowered to draw definitive conclusions regarding mortality.1
"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," said Joe Turk, Chief Executive Officer of Care Enablement at Fresenius Medical Care. "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
multiFiltratePRO will be showcased during ASN Kidney Week 2026 in
The
INDICATION
CIENBY (sodium citrate solution) for extracorporeal use is an anticoagulant indicated for regional citrate anticoagulation (RCA) during continuous venovenous hemodialysis (CVVHD) or continuous venovenous hemodiafiltration (CVVHDF) in adults and pediatric patients weighing greater than or equal to 40 kg.
CONTRAINDICATIONS
CIENBY is contraindicated in patients with:
- known hypersensitivity to active substance
- severely impaired citrate metabolism.
IMPORTANT SAFETY INFORMATION
Hypocalcemia/Hypercalcemia
Due to its mechanism of action, CIENBY causes hypocalcemia. Severe hypocalcemia can lead to serious and life-threatening consequences including arrhythmia, cardiac arrest, seizure, and coma. Correct pre-existing hypocalcemia before initiating treatment with CIENBY to reduce the risk of clinically relevant hypocalcemia.
To prevent depletion of the patient's calcium stores due to calcium loss in the continuous kidney replacement therapy (CKRT) effluent fluid, a separate infusion of calcium in the post-filter (return) bloodline of the extracorporeal circuit is required during CKRT with CIENBY.
Hypercalcemia can occur in patients treated with CIENBY and calcium replacement infusion. Adjust calcium replacement infusion rates and CKRT settings as clinically indicated to maintain electrolytes within target ranges.
In patients undergoing prolonged RCA-CKRT, a decrease in calcium infusion requirements may indicate bone demineralization and parathyroid hormone (PTH) levels and bone turnover markers should be monitored to prevent spontaneous fractures.
Hypernatremia
CIENBY can cause hypernatremia. Use in combination with low-sodium fluids and monitor serum sodium concentrations regularly during and after use of CIENBY.
For patients with pre-existing severe hypo/hypernatremia, slowly correct serum sodium concentration according to physician discretion prior to treatment with CIENBY and consider an anticoagulation method other than RCA.
Hypomagnesemia
CIENBY chelates magnesium ions which can cause hypomagnesemia. Patients with pre-existing magnesium deficiency or those receiving medications known to lower magnesium levels (e.g., proton pump inhibitors) may be at increased risk for hypomagnesemia with CIENBY. Monitor serum magnesium levels regularly during and after use of CIENBY. Supplementation with magnesium may be necessary. Metabolic and Acid-Base Disturbances, including Citrate Accumulation CIENBY can cause metabolic alkalosis or metabolic acidosis, depending on citrate accumulation or citrate insufficiency.
Metabolic Acidosis
In patients with hepatic impairment, shock, or other conditions associated with reduced citrate metabolism, citrate accumulation may occur, which can present as a progressive increase in the ratio of total calcium to ionized calcium, accompanied by metabolic acidosis and ionized hypocalcemia. Monitor acid-base status and calcium parameters frequently during CIENBY administration, especially in patients with hepatic impairment, shock, or other conditions associated with reduced citrate metabolism. Use the total calcium to ionized calcium ratio as a surrogate marker for citrate accumulation. Adjust citrate infusion rates and CKRT settings as clinically indicated based on ongoing monitoring.
Metabolic Alkalosis
Metabolic alkalosis may result from excessive conversion of citrate to bicarbonate in the liver. Use CIENBY in combination with low-bicarbonate fluids.
Drug Interactions
Avoid administration of calcium-containing solutions upstream of the filter as they may reduce the effect of CIENBY.
Overdosage
Excessive infusion causes acute hypocalcemia that may expose the patient to neurological and cardiac complications. In addition, metabolic alkalosis and hypernatremia could also occur due to an excessive amount of CIENBY. Immediately discontinue or lower the dose of CIENBY and administer intravenous calcium in patients with an overdosage.
The safety and effectiveness of CIENBY have not been established for RCA during CVVHD or CVVHDF in pediatric patients weighing less than 40 kg.
Elderly patients may be at risk of impaired citrate metabolism. Frequent monitoring to detect citrate accumulation is recommended.
The most common adverse reactions with CIENBY (incidence >
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Medical Care Renal Therapies Group, LLC at 1-800-323-5188 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.
Dosage forms and Strengths: CIENBY 40 g/L sodium citrate (136 mmol/L citrate) is provided in bag with 1,500 mL clear, colorless solution.
INDICATION
CALREZDY (calcium chloride solution), for extracorporeal use is a source of Calcium indicated for calcium substitution for regional citrate anticoagulation (RCA) during continuous venovenous hemodialysis (CVVHD) or continuous venovenous hemodiafiltration (CVVHDF) in adults and pediatric patients weighing greater than or equal to 40 kg.
IMPORTANT SAFETY INFORMATION
Hyper/Hypocalcemia
Hypocalcemia and hypercalcemia can occur in patients receiving CALREZDY for RCA during continuous kidney replacement therapy (CKRT). Excess dosing with CALREZDY may result in hypercalcemia and insufficient dosing may result in hypocalcemia.
Hypocalcemia should be corrected prior to starting treatment. Patients with hypercalcemia prior to starting treatment should be initiated on a lower starting dose of CALREZDY and monitored closely.
During CALREZDY infusion, regularly check the systemic ionized calcium concentration and increase or decrease the dose as required.
The full effect of calcium dose changes, including calcium released from calcium-citrate chelate complexes, can lead to ionized hypercalcemia up to 12 hours or longer after treatment. In patients with comorbidities affecting calcium metabolism or excretion (such as but not limited to nephrocalcinosis, hypercalciuria and overdose of vitamin D), monitor blood calcium levels more closely before, during, and after treatment.
Arrythmia and Hypotension
CALREZDY infusion during RCA may cause cardiac arrhythmias and decreased blood pressure. Electrocardiogram (ECG) monitoring during administration with CALREZDY is recommended. Synergistic arrhythmias may also occur if calcium and cardiac glycosides are administered together.
Local Clotting of Extracorporeal Circuit
When infused into the extracorporeal circuit, the site of CALREZDY infusion must regularly be inspected for signs of locally developing clotting. If observed, consider changing the extracorporeal circuit.
Drug Interactions
Cardiac Glycosides
Avoid coadministration of CALREZDY in patients receiving cardiac glycosides. Synergistic arrhythmias may occur with concomitant use. The use of calcium chloride may result in hypercalcemia which increases the risk of digoxin toxicity. If concomitant use is unavoidable, monitor ECG closely during administration of CALREZDY.
Calcium Channel Blockers
Administration of calcium may reduce the response to calcium channel blockers.
Drugs That Increase the Risk of Hypercalcemia
Increase frequency of monitoring of calcium concentrations in patients taking concomitant drugs that increase the risk of hypercalcemia (e.g., calcipotriene, estrogen, teriparatide, Vitamin A, and Vitamin D).
The safety and effectiveness of CALREZDY have not been established for calcium substitution in pediatric patients weighing less than 40 kg undergoing CVVHD or CVVHDF with RCA.
OVERDOSAGE
Overdosage of CALREZDY may lead to hypercalcemia. Symptoms of hypercalcemia typically develop when the total serum calcium concentration is > 3 mmol/L [12 mg/dL] or ionized calcium > 1.2 mmol/L [4.8 mg/dL], and include shortening of QT interval, bradycardia, hypertension, anorexia, nausea, vomiting, bowel hypomotility and constipation, muscle weakness, bone pain, decreased concentration, depression, weakness, fatigue, confusion, hallucinations, disorientation, hypotonicity, seizures, and coma. Hypercalcemia effects on kidney include diminished ability to concentrate urine and diuresis.
In the event of overdosage, promptly discontinue CALREZDY, and institute appropriate countermeasures.
The most common adverse reactions with RCA (incidence >
Please see the full Prescribing Information.
Dosage Forms and Strengths: CALREZDY 14.7 g/L calcium chloride dihydrate (100 mmol/L calcium) is provided in a bag with 1,500 mL ready-to-use solution.
Indication for use
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.
About Fresenius Medical Care:
Fresenius Medical Care is the world's leading provider of products and services for individuals with renal diseases of which around 4.5 million patients worldwide regularly undergo dialysis treatment. Through its network of 3,513 dialysis clinics, Fresenius Medical Care provides dialysis treatments for approx. 290,000 patients around the globe. Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME) and on the New York Stock Exchange (FMS).
For more information visit the company's website at www.freseniusmedicalcare.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 various factors, including, but not limited to, changes in business, economic and competitive conditions, legal changes, regulatory approvals, results of clinical studies, 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's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care does not undertake any responsibility to update the forward-looking statements in this release.
© 2026 Fresenius Medical Care. All Rights Reserved. Fresenius Medical Care, the triangle logo, multiFiltratePRO, Ci-Ca, Calrezdy, Cienby, and 5008X are trademarks for which Fresenius Medical Care AG holds rights. All other trademarks are the property of their respective owners. D/N US-CICAT-000005 Rev A 10/2026.
1 Zarbock A, et al. JAMA. 2020;324(16):1629-1639. doi:10.1001/jama.2020.18618
Media contact
Ryan Jimenez
T +1 781 699 3900
ryan.jimenez@freseniusmedicalcare.com
Christine Peters
T +49 160 60 66 770
christine.peters@freseniusmedicalcare.com
Contact for analysts and investors
Dr. Dominik Heger
T +49 6172 609 2525
dominik.heger@freseniusmedicalcare.com
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SOURCE Fresenius Medical Care Holdings, Inc.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did the FDA authorize for Fresenius Medical Care's multiFiltratePRO launch?
The FDA cleared multiFiltratePRO and approved Cienby and Calrezdy on October 19, 2026. Cienby provides regional citrate anticoagulation, while Calrezdy replaces calcium during the specified continuous kidney replacement treatments in adults and pediatric patients weighing greater than or equal to 40 kg.
When will Fresenius Medical Care's multiFiltratePRO be available across the United States?
Fresenius Medical Care plans to begin with a controlled rollout and move quickly to full U.S. availability. No specific date for full availability was given.
Does the clinical study cited for Fresenius Medical Care's launch establish a mortality benefit?
The cited randomized trial was underpowered to draw definitive conclusions regarding mortality. Among critically ill patients with acute kidney injury receiving continuous kidney replacement therapy, regional citrate anticoagulation increased filter life span compared with systemic heparin anticoagulation.