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Germany-based Fresenius Kabi has received the US Food and Drug Administration (FDA) 510(k) approval for its Adaptive Nomogram for use on its Aurora Xi Plasmapheresis System.
Aurora Xi is an automated plasmapheresis system that comprises the Aurora Xi instrument and a Plasmacell Xi disposable set, intended for source plasma collection.
Adaptive Nomogram is an alternate algorithm intended to optimise the collection of plasma, which plays a key role in developing plasma-based therapies.
The alternate algorithm considers each donor’s individual characteristics in calculating the volume of plasma to collect.
It enhances plasma collection by 11.5% per donation while maintaining safe and effective operation and supporting higher production of plasma-derived therapies.
With the Adaptive Nomogram, Aurora Xi allows plasma centres to improve collection and support an enhanced supply of plasma-derived therapies.
Adaptive Nomogram will be first used in Takeda’s BioLife plasma donation centres in the US.
Takeda BioLife Plasma Services global head Hema Tallman said: “This new Adaptive Nomogram will help us personalise each plasma donation and improve our efficiency, while our organization continues to safeguard the health of our donors.
“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 centres in the coming months.”
Fresenius Kabi MedTech president Christian Hauer said: “This FDA clearance marks a significant step forward for Fresenius Kabi in advancing the efficiency and sustainability of plasma collection.
“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 FDA approval was supported by a multicentre, randomised controlled clinical trial, to evaluate the Adaptive Nomogram in Aurora Xi compared to the existing Optimised Nomogram.
In the clinical trial, more than 52,400 procedures were performed at Takeda’s three BioLife Plasma donation centres.
The multicentre study met the primary endpoint of showing that the Adaptive Nomogram resulted in less hypotensive adverse events than the Optimized Nomogram algorithm.
It also showed that the Adaptive Nomogram increased the volume of plasma collected per completed donation by an average of 88mL while increasing procedure time.
Fresenius Kabi said that plasma-derived therapies are important for treating a wide range of conditions, including immune deficiencies, bleeding disorders, and neurological diseases.
The enhanced plasma collection efficiency supports its goal of improving access to critical therapies while supporting the global plasma supply chain, said the healthcare company.
Fresenius Kabi MedTech R&D executive vice president Bryan Blickhan said: “The approval of the Adaptive Nomogram testifies to Fresenius Kabi’s dedication to continuous innovation in the field of apheresis.
“We remain focused on providing state-of-the-art solutions that enable plasma centres to help improve outcomes for both donors and patients.”