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Fenwal Receives FDA Approval for New Solution Used to Store Donated Blood Platelets
Date:12/15/2009

LAKE ZURICH, Ill., Dec. 15 /PRNewswire/ -- Fenwal Inc., a global medical technology company focused on improving blood collection, separation, safety and availability, announced today that the U.S. Food and Drug Administration has granted Fenwal approval to market InterSol® platelet additive solution. Fenwal® InterSol® solution is a specialized product used in combination with human plasma to store donated platelets, a vital blood component used to prevent or treat bleeding.

InterSol® solution is approved for use exclusively with platelets collected using the Fenwal® Amicus® separator, an advanced medical device that collects platelets and other blood components from eligible donors. The FDA approval will allow platelets to be stored in a mixture of 65 percent InterSol® solution and 35 percent plasma.

Traditionally, in the United States, platelets for transfusion are stored in 100-percent donated human plasma. The Fenwal® InterSol® solution replaces a portion of this plasma, which can then be used for other therapeutic purposes.

InterSol® solution is the only platelet additive solution to receive FDA approval. It has been used in Europe for several years.

"The approval of InterSol® is a significant step in the development and marketing of novel processes for the storage of platelets," said Karen Midthun, M.D., acting director of FDA's Center for Biologics Evaluation and Research, in an FDA news release.

InterSol® solution will be available for
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SOURCE Fenwal, Inc.
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