Fresenius Kabi Submits 510(k) Notification for the Aurora Xi Plasmapheresis System Software Version 2.0 with New Nomogram

Matt Kuhn
Fresenius Kabi
Matt.kuhn@fresenius-kabi.com
847-220-3033

Fresenius Kabi, an operating company of Fresenius, announced today it has submitted a 510(k) notification to the U.S. Food and Drug Administration seeking clearance of the Aurora Xi Plasmapheresis System software version 2.0.

The Aurora Xi Plasmapheresis System is currently cleared in the United States for source plasma collection using two existing nomogram algorithms (Standard and Optimized), which determine the amount of plasma to be collected from donors. Aurora Xi Software Version 2.0 includes a new, adaptive nomogram that uses each donor’s unique characteristics to target a collection volume.

“We are excited for the potential of the Aurora Xi Software Version 2.0 to provide U.S. source plasma collectors with a new and proprietary nomogram option. This new nomogram was developed to target a unique volume of plasma for each donor,” said Dr. Christian Hauer, President MedTech at Fresenius Kabi. “Fresenius Kabi is committed to investing in innovation for the source plasma industry which is critical to assure that people who depend on plasma-derived therapies have access to them.”

The 510(k) submission was supported by a multicenter, prospective randomized controlled clinical trial, conducted to evaluate the new nomogram in Aurora Xi Software Version 2.0 compared to the existing nomogram in the predicate device. In the trial, more than 52,400 procedures were completed at three of Takeda’s BioLife Plasma donation centers.

About The Aurora Xi Plasmapheresis System

The Aurora Xi Plasmapheresis System, consists of the Aurora Xi instrument (hardware and software) and a Plasmacell Xi disposable set, is an automated plasmapheresis system intended for Source Plasma collection. Whole blood is drawn from the donor and plasma is separated from concentrated cells using a rapidly rotating separator (membrane filter). The plasma is collected in a collection container and residual cellular components are then returned to the donor.

Source Plasma Collection

Source plasma collection is a process in which human plasma is obtained directly from donors, typically through a procedure called plasmapheresis. This plasma is crucial for creating plasma-based therapies used to treat immune deficiencies, blood disorders, and other medical conditions.

About Fresenius Kabi

As a global health care company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 43,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.

In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status – notably as the only corporation offering both product groups. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.

Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of almost 450 million patients annually. With Vision 2026, as part of the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of health care.

Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing health care solutions on a global scale.

For more information, please visit www.fresenius-kabi.com.

This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.

Management Board: Pierluigi Antonelli (Chairman), Marc Crouton, Andreas Duenkel, Dr. Christian Hauer, Dr. Marc-Alexander Mahl, Dr. Sang-Jin Pak
Chairman of the Supervisory Board: Wolfgang Kirsch
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg - HRB 11654