Adaptive Nomogram Enhances Plasma Collection with FDA Clearance
Fresenius Kabi, a leading provider of lifesaving medicines and technologies, has recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Adaptive Nomogram. This innovative algorithm is designed to optimize plasma collection efficiency and will be integrated into the Aurora Xi Plasmapheresis System. The Adaptive Nomogram takes into account individual donor characteristics to calculate the optimal volume of plasma to collect, resulting in an average 11.5% increase in plasma collection per donation while maintaining safety and efficacy.
A Breakthrough in Plasma Collection
The Aurora Xi Plasmapheresis System, already a trusted tool in plasma centers, now boasts enhanced capabilities thanks to the Adaptive Nomogram. This advancement allows plasma centers to improve collection efficiency, thereby supporting a greater supply of plasma-derived therapies. Dr. Christian Hauer, President of MedTech at Fresenius Kabi, emphasized the significance of this development, stating, “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.”
Clinical Trial Validation
The FDA’s 510(k) clearance was supported by a multicenter, prospective randomized controlled clinical trial. This trial evaluated the Adaptive Nomogram in Aurora Xi Software Version 2.0 compared to the existing Optimized Nomogram. Conducted at three of Takeda’s BioLife Plasma donation centers, the trial involved over 52,400 procedures. The primary endpoint was to demonstrate that the overall rate of significant hypotensive adverse events (SHAEs) in donors using the Adaptive Nomogram was less than double the SHAE rate in donors using the Optimized Nomogram. This endpoint was successfully met. Additionally, the trial showed 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 by an average of 3 minutes and 37 seconds (9.7%).
Collaboration and Future Implementation
Hema Tallman, Global Head of BioLife Plasma Services at Takeda, expressed enthusiasm about the new Adaptive Nomogram, stating, “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. 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.”
Importance of Plasma-Derived Therapies
Plasma-derived therapies are crucial for treating a wide range of conditions, including immune deficiencies, bleeding disorders, and neurological diseases. By increasing plasma collection efficiency, Fresenius Kabi is reinforcing its commitment to improving access to these critical therapies and supporting the global plasma supply chain. Bryan Blickhan, Executive Vice President of MedTech R&D at Fresenius Kabi, highlighted the company’s dedication to innovation, stating, “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 centers to help improve outcomes for both donors and patients.”
Commentary by SuppBase Columnist Alice Winters
The introduction of the Adaptive Nomogram by Fresenius Kabi represents a significant advancement in the field of plasma collection. This innovative algorithm not only enhances the efficiency of plasma collection but also ensures a more personalized donor experience. By leveraging individual donor data, the Adaptive Nomogram optimizes the volume of plasma collected, thereby increasing the overall supply of plasma-derived therapies. This is particularly important given the critical role these therapies play in treating various medical conditions.
The clinical trial results are impressive, demonstrating both the safety and efficacy of the Adaptive Nomogram. The increase in plasma collection volume by an average of 11.5% is a notable achievement, especially when considering the minimal increase in procedure time. This balance between efficiency and safety is crucial in maintaining donor trust and ensuring the continued availability of plasma-derived therapies.
Moreover, the collaboration between Fresenius Kabi and Takeda’s BioLife Plasma Services underscores the importance of industry partnerships in driving innovation. The successful implementation of the Adaptive Nomogram in BioLife Plasma donation centers will likely set a new standard for plasma collection practices.
From a broader perspective, this development highlights the ongoing need for innovation in the healthcare sector. As the demand for plasma-derived therapies continues to grow, advancements like the Adaptive Nomogram are essential in meeting this demand while maintaining high standards of donor care. Fresenius Kabi’s commitment to continuous improvement and innovation is commendable and sets a positive example for the industry.
In conclusion, the Adaptive Nomogram is a game-changer in the field of plasma collection. Its ability to personalize the donation process, increase efficiency, and maintain safety makes it a valuable addition to the Aurora Xi Plasmapheresis System. As this technology is implemented in plasma centers worldwide, it has the potential to significantly impact the availability of life-saving therapies, ultimately benefiting both donors and patients alike.
