Description

The CytoSorb® Absorber, developed by CytoSorbents, is an advanced extracorporeal hemoadsorption device designed for effective blood purification in critically ill patients. This innovative medical device is engineered to remove excess cytokines, bilirubin, myoglobin, bile acids, and specific drugs such as ticagrelor and rivaroxaban from the bloodstream.

Clinical Applications

The CytoSorb® Absorber serves as an adjunctive therapy in various clinical scenarios, including:

• Septic shock
• Liver failure
• Rhabdomyolysis
• Cardiac surgery
• Acute kidney injury
• Severe sepsis
• Endocarditis
• Heart transplantation
• Severe acute pancreatitis

It is also instrumental in managing cytokine storm syndromes associated with conditions like COVID-19, ARDS, and other hyperinflammatory states.

Key Features

• Single-Use Cartridge: Each device is sterile and non-pyrogenic, ensuring safe application.
• Polymer Beads: Utilizes proprietary divinylbenzene polymer beads with a high surface area for effective adsorption.
• Molecular Targeting: Designed to adsorb molecules up to 55 kDa, including pro-inflammatory cytokines such as IL-1β, IL-6, IL-8, and TNF-α.

Compatibility

The device integrates seamlessly with various extracorporeal circuits, including:

• Hemoperfusion (HP)
• Continuous renal replacement therapy (CRRT)
• Intermittent hemodialysis (HD)
• Cardiopulmonary bypass (CPB)
• Extracorporeal membrane oxygenation (ECMO/ECLS)

Operational Parameters

• Blood Flow Rate: Operates effectively within a range of 100–700 ml/min.
• Treatment Duration: Each cartridge is suitable for up to 24 hours of use.
• Priming: Requires priming with sterile isotonic saline, with no need for heparin, making it suitable for patients with heparin-induced thrombocytopenia (HIT).

Anticoagulation and Pressure Management

During therapy, systemic heparinization or regional citrate anticoagulation is necessary. The device is designed to manage pressure effectively, with specific parameters outlined for optimal performance.

Sterilization and Storage

• Sterilization: Achieved through gamma irradiation.
• Shelf Life: Three years, with storage temperatures ranging from 1°C to 40°C.

Certifications

The CytoSorb® Absorber is CE marked as a Class IIb medical device, ensuring compliance with rigorous safety and quality standards. It is latex-free and PHT-free, aligning with biocompatibility requirements per ISO10993.

Packaging

Available in various packaging options, including boxes of 6 or 12 adsorbers, with kits tailored for specific circuit integrations. Each kit includes necessary accessories for seamless clinical application.

Clinical Integration

Designed for easy integration into blood circuits, the device is recommended for early initiation within 12–24 hours of diagnosis. Continuous treatment is advised, with therapeutic drug monitoring to adjust dosages as needed.

Safety and Efficacy

Clinical studies indicate that the CytoSorb® Absorber effectively reduces cytokine levels and other targeted substances, potentially lowering vasopressor requirements and transfusion needs in cardiac surgery. While evidence on major clinical outcomes varies, the device is consistently reported as safe and well-tolerated.