LAKE ZURICH, Ill.– Fresenius Kabi, an operating company of Fresenius, specializing in lifesaving medicines and technologies, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Adaptive Nomogram – an alternate algorithm that will be available in the Aurora Xi Plasmapheresis System – designed to optimize plasma collection efficiency.
The newly cleared Adaptive Nomogram considers each donor’s individual characteristics in calculating the volume of plasma to collect, enabling an average 11.5% increase in plasma collection per donation while maintaining safe and effective operation. The Aurora Xi Plasmapheresis System now benefits from enhanced capabilities that allow plasma centers to improve collection efficiency and support a greater supply of plasma-derived therapies.
“This FDA clearance marks a significant step forward for Fresenius Kabi in advancing the efficiency and sustainability of plasma collection,” said Dr. Christian Hauer, President, MedTech at Fresenius Kabi. “The Adaptive Nomogram represents a breakthrough in donor experience innovation, leveraging donor data to deliver one of the most personalized and optimized plasma collection processes available today.”
The 510(k) clearance was supported by a multicenter, prospective randomized controlled clinical trial, conducted to evaluate the Adaptive Nomogram in Aurora Xi Software Version 2.0 as compared to Aurora Xi with the existing Optimized Nomogram. The trial entailed more than 52,400 procedures at three of Takeda’s BioLife Plasma donation centers. The primary endpoint – to demonstrate that the overall rate of significant hypotensive adverse events (SHAEs, IQPP DAE Classification 1.2-1.6) in donors using the Aurora Xi Adaptive Nomogram algorithm was less than double the SHAE rate in donors using the Aurora Xi Optimized Nomogram algorithm – was met. The trial also demonstrated that the Adaptive Nomogram increased the volume of plasma collected per completed donation by an average of 88.0 mL (11.5%, plasma without anticoagulant) while increasing procedure time an average of 3 minutes 37 seconds (9.7%).
“This new Adaptive Nomogram will help us personalize each plasma donation and improve our efficiency, while our organization continues to safeguard the health of our donors,” said Hema Tallman, Global Head of BioLife Plasma Services at Takeda. “We were grateful for the opportunity to collaborate with Fresenius Kabi on the clinical trial, and we look forward to being the first company to introduce it in our plasma donation centers in the coming months.”
Plasma-derived therapies are essential for treating a wide range of conditions, including immune deficiencies, bleeding disorders, and neurological diseases. By increasing plasma collection efficiency, Fresenius Kabi reinforces its commitment to improving access to these critical therapies while supporting the global plasma supply chain.
“The approval of the Adaptive Nomogram testifies to Fresenius Kabi’s dedication to continuous innovation in the field of apheresis,” said Bryan Blickhan, Executive Vice President, MedTech R&D at Fresenius Kabi. “We remain focused on providing state-of-the-art solutions that enable plasma centers to help improve outcomes for both donors and patients.”
