<0> Final step completed for applying CE markAurora system to be marketed in Europe </0>
<0> Fenwal Receives 60601-1 3rd Edition Certification for Aurora™ Plasmapheresis System </0>
Fenwal, a Fresenius Kabi company, announced today it has received 60601-1 3rd edition certification for the Aurora™ plasmapheresis system designed for collection of plasma. 60601-1 3rd edition is the latest international consensus standard representing the current “state of the art” for medical device design and allows Fenwal to market the Aurora system in Europe. Aurora, which received U.S. FDA 510(k) clearance in April 2012, represents the latest Fenwal advancement in plasma collection technology.
“The Aurora system represents a significant advancement for plasma collection professionals,” said William Cork, executive vice president and chief technology officer for the Fresenius Kabi Medical Devices division. “Aurora features powerful capabilities, such as an interactive touch-screen display with intuitive menus and icons, and works with Fenwal DXT® Relay software.” This software supports two-way, wireless data communication designed to eliminate manual steps and increase operator and donor satisfaction.
The Aurora system continues to use the company’s proven and proprietary filtration separation method which enables the collection of virtually cell-free plasma and meets European requirements without further filtration.
The Aurora system offers new features that improve work flow and help ensure a successful collection. Intuitive on-screen instructions simplify training for operators and provide troubleshooting assistance. An LCD display allows donors themselves to see how their donation is progressing.
The Aurora system can support remote procedure set up and paperless documentation when used with the Fenwal DXT Relay software and a plasma center’s donor management system. With remote procedure set up, the Aurora system can be programmed automatically based on donor registration information. These features help assure data accuracy, documentation compliance, and a more streamlined procedure.
The Fenwal DXT Relay software also provides plasma center professionals with easy-to-read, on-demand reports that consolidate donor and procedure data from multiple Aurora systems at different locations. The reports track specific performance indicators and can be used to identify opportunities for operational improvement and training. The Fenwal DXT Relay software was built with open architecture so that it can seamlessly integrate with existing plasma center systems without requiring expensive, proprietary add-ons.
Plasma is the liquid portion of blood that contains valuable proteins used to treat burn victims, bleeding disorders, human immune deficiencies, and other chronic or genetic disorders. Unlike other blood components, which are stored at room temperature or refrigerated, plasma is frozen and thawed prior to fractionation or transfusion.
Plasmapheresis is an automated process in which plasma is taken from donated blood and the remaining components – primarily red cells and platelets – are returned to the donor. Source plasma is used by pharmaceutical companies that produce therapies from plasma-derived proteins.
Fenwal is focused on improving transfusion medicine through unique expertise in blood separation, collection, filtration, storage and transfusion. Acquired by Fresenius Kabi in December 2012, Fenwal offers a broad range of products and services for the automated and manual collection of blood and blood components. For more information please visit .
About Fresenius Kabi
Fresenius Kabi () is a leading global health care company that focuses on pharmaceuticals and medical devices used to care for critically and chronically ill patients inside and outside the hospital. The company’s products include intravenous specialty and generic medicines, infusion therapies, clinical nutrition and related medical devices. Within transfusion technologies, we offer products for whole blood collection and processing, plasma collection, transfusion medicine and cell therapies. Its roots go back more than 100 years to the founding of our parent company, Fresenius SE, in Bad Homburg, Germany, where the company is headquartered today.
Forward Looking Statement
To the extent 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 does not undertake any responsibility to update the forward-looking statements in this release.
Fenwal, Aurora and DXT are trademarks of Fenwal Inc. Fresenius and Fresenius Kabi are trademarks of Fresenius SE & Co.