Fenwal Secures New FDA Clearance for Device Designed to Help Increase Plasma
Available for Transfusion
LAKE ZURICH, Ill. -- March 19, 2013
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
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
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.
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