Your Questions. Our Answers.

• Refer to the product IFU’s for complete information on the warnings, precautions, and contraindications of each device.

 

• IFU’s are available on request: > request now

The Instructions for Use (IFU) of a medical device are an integral part of the CE-marked approval documentation.
 

They are reviewed by the Notified Body during the conformity assessment process and define the intended purpose, indications, conditions of use, and safety instructions of the device.
 

Accordingly, these specifications describe device use parameters within the approved indication (“on-label use”).
 

Use of a medical device outside its technical specifications is not permitted.
 

Supplementary materials such as Quick Setup Guides or training documents reflect and summarize the content of the official IFU, but do not replace it as the legally binding reference.

From a hygienic perspective, the CytoSorb adsorber should be used as soon as possible after priming.

 

It should be handled according to standard hygienic principles, similar to prepared infusion solutions or extracorporeal circulation systems that are ready for clinical use.
 

When handled under appropriate hygienic conditions, CytoSorb with adapters is comparable to other components of the extracorporeal circuit in terms of material composition and hygiene requirements.
 

Therefore, the adsorber must be replaced after a maximum of 24 hours to maintain performance and compliance with validated use conditions.
 

The CytoSorb Therapy Booklet “Treatment Goals & Rationale” specifies that “treatment duration and the indication for adsorber exchange depend on the clinical course; the maximum treatment time per adsorber is 24 hours.”

The shelf life is 3 years.

CytoSorb can be disposed of together with potentially infectious waste, such as dialysis filters and infusion systems.

• Local hygiene guidelines apply.
• CytoSorb does not contain any toxic ingredients that would prevent disposal with other standard infectious waste.

The adsorber should be stored in its outer packaging, at an ambient temperature of +1 – 40 °C (34 – 104 °F).

CytoSorb is CE-certified and can be used in all countries where this is the basis for use or local registration. CytoSorb is also available in countries outside of the EU.
 
Please check availability and our representative in your country cytosorbents.com/distributors.

No. CytoSorb does not remove endotoxin, which is primarily involved in gram-negative sepsis.
 
In contrast to endotoxin adsorbers that focus on removal of lipopolysaccharide (LPS), CytoSorb targets circulating inflammatory mediators and may therefore be considered in clinical settings characterized by systemic hyperinflammation, including:

• Non-infectious conditions (e.g., polytrauma, burn injury, inhalation trauma, pancreatitis), and
• Infectious conditions, including gram-negative and gram-positive bacterial infections.

The development of secondary organ dysfunction in systemic inflammation is largely driven by circulating cytokines and inflammatory mediators that can affect tissues distant from the initial site of injury or infection. Therefore, the reduction in circulating cytokines and inflammatory mediators is intended to control the systemic hyperinflammatory response and support organ function recovery.
 

Current state-of-the-art understanding suggests that:

• The removal of cytokines and other inflammatory mediators from blood via hemoadsorption may contribute to a temporary reduction in their circulating concentrations.
• Lower circulating mediator levels have been associated in clinical observations with improved hemodynamic stability and reduced vasopressor requirements, although these effects depend on individual patient conditions and clinical context.
• Stabilization of endothelial integrity and attenuation of capillary leak have been discussed in the literature as potential secondary effects of cytokine reduction.
• By influencing circulating mediator levels, inflammation-related tissue stress may be modulated, which could support organ function during systemic inflammatory states.
• Experimental studies have indicated that removal of excessive inflammatory mediators may lead to a rebalancing of immune cell signaling and chemokine gradients, which may help redirect immune responses toward local sites of inflammation.

These mechanisms are based on published experimental and clinical findings and should be interpreted as supporting hypotheses rather than proven therapeutic effects. Clinical decision-making should always rely on the overall patient condition and established treatment protocols.

Yes. CytoSorb is designed to adsorb hydrophobic molecules with a molecular weight of up to approximately 60 kDa. The removal of substances occurs in a concentration-dependent manner, meaning that higher plasma concentrations can lead to greater adsorption. At lower concentrations, removal efficiency decreases, maintaining the physiological balance of circulating mediators.

• The adsorption spectrum includes both pro- and anti-inflammatory mediators that may reach elevated plasma levels during systemic inflammation.
• Published data have shown that physiologically important plasma components such as albumin may also bind to the polymer surface, but typically only in small, clinically non-relevant amounts.

 

• The intended purpose of CytoSorb Therapy is to reduce excessive levels of inflammatory mediators from blood or plasma as part of extracorporeal blood purification, thereby contributing to modulation of dysregulated immune responses.
• Elevated concentrations of both pro- and anti-inflammatory cytokines have been reported in the literature to correlate with adverse outcomes and increased mortality in critical illness.

CytoSorb is a CE marked whole blood adsorber designed for the reduction of specific substance groups from whole blood. CytoSorb is not yet approved or cleared in the United States or Canada.

• It can be integrated quickly and easily into an existing extracorporeal circuit (ECC), such as CRRT, ECMO, or cardiopulmonary bypass systems.
• The device is designed to adsorb hydrophobic molecules with molecular weights of up to approximately 60 kDa, including various cytokines and inflammatory mediators that can accumulate during systemic inflammation.
• CytoSorb is indicated for intraoperative use during surgical procedures involving cardiopulmonary bypass to remove the P2Y12 inhibitor ticagrelor and/or the factor Xa inhibitor rivaroxaban from blood.

No. CytoSorb is an adsorber technology in which candidate substance bind to the adsorber material in a concentration dependent fashion (hydrophobic molecules with a molecular weight of up to approximately 60 kDa).

Adsorber:

• CytoSorb is a “blood in – blood out” product (whole-blood adsorber). There is no secondary circulation with albumin, no dialysate, no ultrafiltrate.
• Candidate substances with a molecular weight less than 60 kDa and hydrophobic properties can be adsorbed onto the surface within the porous structure of the polymer beads.

Hemofilter/Dialyzer:

• Water-soluble substances are filtered out of the blood.
• Dialyzers are based on the principles of diffusion and convection.
• Blood components interact with a dialyzate solution through a semipermeable membrane.
• High cut-off membranes have higher size thresholds for the elimination of substances. In addition to the desired substances, however, useful molecules such as albumin can also be removed in the process.

A collection of publications with varying levels of evidence, abstracts, and article links can be found in the CytoSorb® Literature Database (cytosorbents.com/lit-db).

• To date, published clinical studies have described the safety and performance of CytoSorb® Therapy across different clinical settings.
• As of December 2025, the literature database includes more than 1,100 entries, of which over 700 are peer-reviewed publications.
• Based on post-market experience of over 300,000 individual applications (as of December 2025), no unexpected device-related serious adverse events have been reported.

Published evidence and post-market data collectively describe CytoSorb® Therapy as well characterized from a safety perspective when used according to its intended purpose.

A number of studies on various CytoSorb indications in both critical care and cardiac surgery settings are being conducted in collaboration with recognized scientific partners.
 
For an overview of published literature, please visit our database: cytosorbents.com/lit-db.
 
Further information is also available at www.clinicaltrials.gov (search term: CytoSorb) or cytosorbents.com/studies-registry.

Information on reimbursement in Germany can be found here, for all other countries please contact us.

This can occur under certain conditions and may indicate that

• the cause of cytokine release persists (e.g., insufficient focal control), or
• a new trigger for systemic inflammation has appeared.

CytoSorb® Therapy itself does not induce a specific rebound effect.

The use of IL-6 as a surrogate marker for clinical monitoring is possible; however, the absolute baseline value does not necessarily reflect disease severity. The course of IL-6 levels should be interpreted in the context of the overall clinical picture.

Anticoagulation treatment is possible with both heparin and citrate. If CytoSorb is used as a stand-alone therapy, only heparin may be used for anticoagulation. Citrate is contraindicated in this setup.
 
In general, no special protocol adjustments are required for CytoSorb. The instructions by the device manufacturer must be followed.
 
In case of systemic anticoagulation with heparin the following applies:
 
As a matter of principle, anticoagulation must be effective before starting treatment. This means to first increase the aPTT to the target value and only then start the extracorporeal procedure.

Recommended target values when using heparin:

• aPTT: 60 – 80 sec (activated partial thromboplastin time. This value corresponds to 2 – 3 times the baseline value).
• ACT: 160 – 210 sec (activated clotting time standard value 100 – 130 sec)
• AT III: 75 – 120% (antithrombin III)
• Caution: HIT (heparin-induced thrombocytopenia).

These target values are controlled according to the respective standards of care. The decision regarding dosage and target values is always the responsibility of the treating physicians.
 
For regional anticoagulation with citrate, the following applies:

• Initial dose, blood flow rate, control and adjustment of calcium and citrate is according to protocol.
• Citrate and calcium are to be added at the usual points of the extracorporeal circulation.
• Control of ionized calcium (CRRT circuit and patient) a few minutes after the start of treatment and at regular intervals of 8 – 12 hours is recommended.

The decision regarding dosage and target levels is always the responsibility of the treating physicians.

Yes — under specific circumstances this is possible, but only when CytoSorb is used within a CRRT or hemoperfusion/hemoadsorption (HP/HA) system.

• CytoSorb is a single-use medical device and must remain integrated within the same extracorporeal circuit after initial connection.
• Temporary interruption of therapy (e.g., for diagnostics or surgical procedures) is possible provided that the CytoSorb adsorber remains part of the extracorporeal circuit, as is typical in CRRT systems.
• Blood return from the extracorporeal circuit to the patient must be performed according to the CRRT system manufacturers instructions for use (IFU) for an “interruption of a CRRT treatment.

The CRRT device may continue to circulate while the patient is temporarily disconnected, in accordance with the CRRT system IFU instructions.

• Local hygiene regulations and the specifications of the extracorporeal system manufacturer must be strictly followed during any interruption of therapy.
• Removal of the CytoSorb cartridge from one extracorporeal system (e.g., a heart–lung machine or ECMO system) and reinstallation into another system is not permitted, for hygienic and safety reasons.

To support adequate elimination performance, a recommended blood flow rate of 150–700 mL/min should be maintained.
 
The minimum blood flow rate is 100 mL/min. Blood flow rates below this threshold may be associated with an increased risk of clotting.
 
Please refer to the instructions for use provided by the manufacturer of the primary circuit.

CytoSorb Therapy and Dependency on the Extracorporeal System

 
CytoSorb Therapy is always used as part of an extracorporeal circulation and functions as a passive client of the host extracorporeal (EC) system. The performance of the therapy is therefore dependent on the operating conditions of the host system, including the achievable blood flow rates. Higher blood flow rates of the host EC system may increase the volume of blood processed over time and thereby the potential extent of substance removal by CytoSorb.

 
The selection, configuration, and operation of the extracorporeal system, including vascular access, remain at the discretion of the treating physician.

 
Vascular Access and System Requirements

• The safety and performance of CytoSorb Therapy require an adequately performing extracorporeal circuit.
• Requirements for vascular access location and type depend on the type of extracorporeal circulation used.
• Vascular access should allow maximum blood flow within the extracorporeal circulation.
• For standalone CytoSorb use (hemoperfusion/hemoadsorption), a vascular access equivalent to that used for CRRT treatments is required.

CytoSorb Therapy can be applied in combination with standard hemoperfusion devices, CRRT systems, ECMO/ECLS circuits, or heart–lung machines that are already in clinical use.

• The preparation and set-up of the CytoSorb adsorber typically require only a few minutes.
• The cartridge is safely and easily integrated into an existing extracorporeal circulation (ECC) system.
• CytoSorb can be used in stand-alone hemoperfusion mode or in combination with dialysis filters.
• Standardized adapter kits are available for preparation and integration into various ECC systems.

For use of CytoSorb follow the instructions of use of Cytosorb 300, the host system and all other components used.

• CytoSorb is indicated for the removal of cytokines, bilirubin, and myoglobin from blood. When clinically indicated, initiation of therapy at an early stage may support optimal treatment outcomes.
• Please reconsider the use in patients who are already in therapy-refractory shock for several days.

CytoSorb is indicated for the removal of cytokines, bilirubin, and myoglobin from blood.
The duration of CytoSorb therapy should be determined based on the patient’s clinical response and improvement, taking into account the overall clinical course and response to treatment.
 
CytoSorb Therapy should be continued until clinical stabilization is achieved, as reflected by:

• Improvement in hemodynamic stability, including a reduction in vasopressor requirements

Improvement in impaired organ function, including:

• Improved kidney function
• Improved lung function, including reduced ventilatory support requirements
• Improved liver function

In patients receiving antithrombotic therapy, CytoSorb use may be considered until stabilization is achieved with regard to bleeding risk associated with ticagrelor, rivaroxaban, or apixaban, in accordance with approved use and clinical judgment.
 
Deterioration of the patient’s condition after cessation of CytoSorb therapy may indicate the need to resume treatment, for example in the setting of ongoing inflammatory burden or an additional inflammatory insult (“second hit”).

CytoSorb is indicated for the removal of cytokines, bilirubin, and myoglobin from blood.
The assessment of treatment response should be based primarily on the patient’s overall clinical course.
 
Indicators of clinical stabilization may include:
 
Hemodynamic stability

• Decrease in vasopressor requirements (or no further dose escalation required).
• Reduction in fluid requirements.
• Stabilization or no further increase in lactate levels.

Reduction in inflammatory markers

• Decrease in interleukin-6 (if measured) and other inflammatory/infection parameters such as leukocytes, procalcitonin (PCT), or C-reactive protein (CRP).
• When interpreting PCT levels, note that PCT can be partially adsorbed by CytoSorb; therefore, an increase during ongoing therapy should be evaluated cautiously.

Stabilization of organ function

• No further deterioration in liver function (synthesis or detoxification capacity).
• No increase in respiratory support requirements.

Clinical judgment should always guide interpretation, and no single parameter alone should be used to determine therapeutic success.

The timing of CytoSorb Therapy should be determined based on the patient’s clinical condition and overall treatment concept.
 
Clinical experience and published data suggest that the initiation of hemoadsorption, with the goal of cytokine removal, may be considered during the early phase of septic shock or systemic hyperinflammation (early SIRS), when inflammatory processes are still potentially reversible.
 
The potential benefit of therapy may be limited in patients with advanced or irreversible organ failure.
Therefore, among candidate patients, earlier initiation is preferred, and available clinical data suggest improved clinical outcomes compared with delayed initiation.

 
General indicators that may support consideration of CytoSorb Therapy include:

• Clinical signs of systemic hyperinflammation
• Evidence of capillary leak (e.g., marked positive fluid balance)
• Elevated interleukin-6 (IL-6) levels (e.g., > 500 pg/mL) may support, but are not required for, treatment consideration

In all cases, the patient’s overall clinical picture should be the decisive factor when determining indication, timing, and assessment of therapy response.

CE mark approved indications:
 
CytoSorb 300 IFU 03/2023
CytoSorb is indicated for use in conditions where elevated levels of cytokines and/or bilirubin and/or myoglobin exist. CytoSorb is indicated for use intraoperatively during cardio-pulmonary bypass surgery for the removal of P2Y12-Inhibitor Ticagrelor and/or Factor Xa-Inhibitor Rivaroxaban. Results from current studies suggest that CytoSorb may be administered for up to 7 consecutive days. Maximum Treatment Time per Device: 24 Hour.

 
Typical clinical application areas include:

• Intensive care units in support of critically ill patients (i.e. sepsis)
• Cardiac surgery, including complex procedures that may require additional support postoperatively

Additional clinical experience:
 
Published case series and reports have described the use of CytoSorb in various hyper-inflammatory and toxin-related conditions, such as:

• Polytrauma and rhabdomyolysis
• Severe burns
• Acute pancreatitis
• Different forms of liver failure
• Severe cardiogenic shock
• Complications following cardiac surgery
• Necrotizing fasciitis
• Systemic hyperinflammation associated with ECMO therapy

* The clinical examples listed describe settings characterized by elevated circulating substances such as cytokines, bilirubin, myoglobin, or selected antithrombotic agents. These examples are provided for scientific context only and do not define or expand the approved indications of the device.
 
Decisions regarding use should always be made by the treating physician, considering the patient’s overall condition and institutional protocols.