LAKE ZURICH, Ill. – March 24, 2014
Fenwal, a Fresenius Kabi company, announced today it is has received FDA clearance to include new clinical data in the product label of its platelet additive solution, InterSol™ (PAS 3). A multi-center, non-randomized, open-label retrospective medical chart review study involving about 14,000 transfusions looked at adverse events related to platelet transfusion with and without additive solution. Platelet transfusions using Fenwal InterSol led to a 0.55 percent adverse event reaction rate, while transfusions using only plasma platelets led to a 1.37 percent adverse event reaction rate.
Clinical experience has suggested that allergic transfusion reactions may be reduced by replacing a portion of the total plasma volume with platelet additive solution. Fenwal InterSol solution replaces approximately 65 percent of the plasma used for platelet storage, on platelets collected on the Fenwal Amicus® separator. The results of this study are consistent with these previous findings.
No adverse safety trends were identified after a review of all the adverse events by the Independent Clinical Events Committee. Platelet transfusions using Fenwal InterSol resulted in a 0.29 percent allergic reaction rate, while transfusions using only plasma platelets resulted in a 0.82 percent allergic reaction rate. Febrile Non-Hemolytic Transfusions Reaction events were associated with 0.17 percent of platelet transfusions with Fenwal’s InterSol and 0.50 percent of transfusions with plasma platelets.
“Research and clinical practice show the importance of transfusing only the blood component necessary for the patient. These new data confirm the safety of Fenwal InterSol platelets and should give our customers continued confidence when serving their patients,” said Dean Gregory, president, Medical Devices, for Fresenius Kabi North America. “Also the use of a platelet additive solution frees up additional donor plasma that blood centers can use for other patients.”
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 sever trauma. Platelets are stored at room temperature with continued agitation.
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.