LAKE ZURICH, Ill. -- (BUSINESS WIRE) -- Fenwal Inc., a Fresenius Kabi company, announced today it has received clearance from the U.S. Food and Drug Administration for a functionally closed disposable set used on the Fenwal Autopheresis-C® system to collect plasma for processing into Fresh Frozen Plasma.
The Autopheresis-C system is used worldwide to collect plasma from human donors. Plasma, the liquid portion of blood, is either frozen for future transfusion, or processed by pharmaceutical companies into a range of therapies made from plasma-derived proteins.
The FDA clearance announced today is for a functionally closed disposable set used with the Autopheresis-C system to collect plasma that is processed into Fresh Frozen Plasma for transfusion. The closed design of the new set allows thawed plasma to be stored for up to an additional four days.
“Because of the longer shelf life, this Fenwal set helps increase availability of plasma for transfusion,” said Dean Gregory, president of Medical Devices in North America. “At the same time, this new clearance expands our portfolio of plasma-collection products for blood centers, and responds directly to a need many blood centers have expressed to us for enhanced plasma collection, especially for AB type donors.”
The functionally closed Autopheresis-C disposable set is designed for safety and ease of use with a pre-attached needle and collection containers. The Autopheresis-C system labeling allows for the collection of up to 885 milliliters of plasma from qualifying donors, providing up to four therapeutic doses.
Plasma and plasma-derived proteins are used to treat burn victims, bleeding disorders, human immune deficiencies, and other chronic or genetic disorders. Nearly 5 million units of plasma are transfused annually in the United States. Unlike other blood components, which are stored at room temperature or refrigerated, plasma is frozen and thawed prior to transfusion.
About plasma collection
Through Fenwal, Fresenius Kabi offers a comprehensive portfolio of products for the collection of plasma, as well as other blood components, for blood and plasma centers. Last year, the company introduced the Aurora® plasmapheresis system, a new source plasma collection system with two-way data management capabilities. The company’s Alyx® and Amicus® automated component collection systems allow for the collection of concurrent plasma, in addition to other blood components.
Fenwal Inc. is a medical technology company 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. Fenwal products and advanced collection and separation technologies are used worldwide. For more information please visit www.fenwalinc.com.
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.com) is a leading international health care company focusing on products for the therapy and care of critically and chronically ill patients inside and outside the hospital. The company’s product portfolio comprises a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products as well as the medical devices for administering these products. Within transfusion technologies, Fresenius Kabi offers products for whole blood collection and processing as well as for transfusion medicine and cell therapies. Fresenius Kabi is a wholly owned subsidiary of the health care group Fresenius SE & Co. KGaA.
Forward Looking Statement
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.