FDA Nods Fresenius Kabi's Adaptive Nomogram for Enhanced Plasma Collection

The U.S. Food and Drug Administration (FDA) has approved 510(k) clearance for Fresenius Kabi’s Adaptive Nomogram, a different algorithm to be included in the Aurora Xi Plasmapheresis System aimed at enhancing plasma collection efficiency. The recently approved Adaptive Nomogram takes into account the specific traits of each donor when determining the plasma volume to be collected, allowing for an average increase of 11.5% in plasma collection per donation while ensuring safe and effective procedures. 

The Aurora Xi Plasmapheresis System has gained enhanced features that enable plasma centers to boost collection efficiency and provide a larger supply of plasma-derived therapies.

"This FDA approval represents an important advancement for Fresenius Kabi in enhancing the efficiency and sustainability of plasma collection," stated Dr. Christian Hauer, President, MedTech at Fresenius Kabi. The Adaptive Nomogram signifies a significant advancement in enhancing donor experiences, utilizing donor information to provide one of the most tailored and efficient plasma collection procedures currently accessible.

The 510(k) clearance was backed by a multicenter, prospective randomized controlled clinical trial aimed at assessing the Adaptive Nomogram in Aurora Xi Software Version 2.0 against Aurora Xi using the current Optimized Nomogram. The main objective—to show that the total rate of notable hypotensive adverse events in donors utilizing the Aurora Xi Adaptive Nomogram algorithm was below twice the SHAE rate in donors employing the Aurora Xi Optimized Nomogram algorithm—was achieved.