Description

The CYTOSORB EC PRIMING SET ECMO by CytoSorbents is an advanced medical device engineered for critical care environments. This sterile, single-use device is designed to integrate seamlessly into ECMO (Extracorporeal Membrane Oxygenation) and other extracorporeal circuits, providing essential blood purification for critically ill patients.

Functionality

Utilizing innovative adsorbent polymer beads, this device effectively removes cytokines and other inflammatory mediators from the blood. Its primary aim is to reduce pro-inflammatory cytokine levels, offering therapeutic support for patients aged 18 and older, including those with severe COVID-19 symptoms experiencing respiratory failure.

Design and Compatibility

• Non-Pyrogenic and Sterile: Ensures safe, single-use application.
• High Surface Area Beads: The adsorbent beads provide a vast surface area, allowing selective adsorption of molecules up to approximately 60 kDa, while excluding larger proteins like albumin and immunoglobulins.
• Standard Bloodline Compatibility: Equipped with female Luer connectors, enhancing integration with existing medical equipment.

Technical Specifications

• Blood Flow Rates: Operates effectively within 200–400 mL/min, with a validated range of 100–700 mL/min.
• Priming Volume: Blood priming volume ranges between 120–150 mL.
• Flow Resistance: Maintains flow resistance at 300 mmHg for blood flow rates below 500 mL/min.
• Temperature Range: Suitable for storage and use between 1–40°C.
• Sterilization: Achieved through gamma irradiation, with isotonic saline as the storage fluid.

Instructions for Use

The device includes comprehensive instructions for priming and circuit integration, ensuring efficient and safe operation. Key steps involve:

• Elevating the priming bag and managing pump speeds to remove air from the circuit.
• Ensuring bubble-free priming and secure connections in temporary VAD circuits.

Contraindications and Warnings

• Not suitable for HIT-positive patients without alternative anticoagulation, those with very low platelet counts, acute sickle cell crisis, profound immunosuppression, or pregnancy.
• Potential side effects include hypersensitivity reactions and other events common to extracorporeal treatments.
• Emphasizes single-use only and mandates trained personnel for administration.

Regulatory Status

The device holds CE 0344 certification and is authorized under FDA Emergency Use Authorization (EUA) for specific COVID-19 applications. It is not FDA approved for general use, and distribution must adhere to EUA conditions, including proper labeling and documentation.

This comprehensive design and regulatory compliance make the CYTOSORB EC PRIMING SET ECMO a vital tool in managing inflammatory responses in critical care settings.