Fresenius Kabi seeks FDA approval for innovative plasmapheresis software

Fresenius Kabi, a global healthcare company, has filed a 510(k) notification with the U.S. Food and Drug Administration (FDA) for its Aurora Xi Plasmapheresis System software version 2.0. The updated software introduces a proprietary, adaptive nomogram that personalizes plasma collection based on individual donor characteristics, a move set to revolutionize source plasma collection.

The Aurora Xi system is an automated plasmapheresis platform designed to separate plasma from whole blood, essential for creating plasma-derived therapies. While the current system employs two pre-set algorithms—the Standard and Optimized nomograms—the new adaptive nomogram in software version 2.0 aims to improve efficiency by tailoring collection volumes to each donor’s physiological profile. This innovative step addresses growing global demand for plasma-based treatments used to combat immune deficiencies, blood disorders, and other critical conditions.

Improved approach to plasma collection

The Aurora Xi system integrates advanced hardware, software, and disposable components to ensure a streamlined plasmapheresis process. Using a high-speed rotating membrane filter, the device efficiently extracts plasma while returning residual cellular components to the donor, optimizing donor safety and comfort.

Dr. Christian Hauer, President of MedTech at Fresenius Kabi, emphasized the significance of this development. He highlighted that the enhanced system reflects Fresenius Kabi’s commitment to advancing plasma collection technologies, ensuring that patients reliant on plasma-based therapies can access reliable treatments.

Supporting its FDA submission, the company conducted a rigorous multicenter, prospective randomized clinical trial. The study, performed across three Takeda BioLife Plasma donation centers, included over 52,400 plasma collection procedures. The results demonstrated the superior performance of the new adaptive nomogram compared to existing algorithms, paving the way for regulatory approval.

addressing rising demand for plasma-based therapies

Source plasma, derived directly from donors via plasmapheresis, serves as the foundation for therapies treating chronic and life-threatening diseases. With demand for these treatments rising globally, the healthcare sector faces a critical need for innovative and efficient plasma collection technologies.

Industry experts believe that Fresenius Kabi’s software update could transform the industry by improving operational efficiency and enhancing donor experiences. If approved, U.S. plasma collection centers will gain access to a more sophisticated system that ensures donor-specific plasma volumes while maintaining rigorous safety and compliance standards.

The submission is part of Fresenius Kabi’s broader strategy to drive innovation within the plasma collection industry. By leveraging cutting-edge technologies, the company seeks to address both current challenges and future demands in the healthcare landscape.