Fresenius Kabi AG Wins FDA Clearance For 7-Day Platelet Storage Using Fenwal Amicus System
LAKE ZURICH, Ill.--(BUSINESS WIRE)--
Fresenius Kabi, a global health care company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition, announced today that the U.S. Food and Drug Administration (FDA) has cleared a labeling change that permits blood centers to use the Fenwal Amicus® system for the storage of Amicus-derived platelets in plasma for up to seven days.
“Our customers now have the ability to store and use seven-day platelets processed by Amicus to help meet an important need in transfusion medicine," said Dean Gregory, president, Medical Devices, for Fresenius Kabi North America. "We designed Amicus to help optimize apheresis programs for blood-collection professionals. With this new clearance, the Amicus system becomes an even more versatile choice.”
Until now, platelets have been limited to a shelf life of five days before expiration due to the absence of appropriate bacterial testing methods and appropriate instructions for use. The new indication for use states that blood centers that wish to store apheresis-derived platelets for seven days must label every product with a statement that the product must be tested with a bacterial detection device cleared by FDA and labeled as a “safety measure.”
To support this requirement, Fresenius Kabi is the exclusive distributor of the Verax Platelet PGD® test, a rapid platelet PGD test that is cleared by the FDA as a “safety measure” for leukoreduced apheresis platelets within 24 hours prior to transfusions.
Platelets are the components of blood that help control bleeding. They are used in the treatment of cancers, compromised immune systems, organ transplant, blood disorders, and severe trauma. Platelets are stored at room temperature with continued agitation.
About the Fenwal Amicus® system
The Fenwal Amicus® system is an advanced cell separation system used by hospitals and blood centers to collect platelets, platelets with concurrent plasma and red cells, and mononuclear cells used for therapeutic applications and clinical research.
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany.
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- Health Care Industry
- Fresenius Kabi
- Food and Drug Administration
Fresenius Kabi
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