FDA grants approval to market InterSol platelet additive solution

Dec 15 2009

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 platelets collected with the Fenwal® Amicus® system, pending clearance of a 510(k) application under review by the FDA.

Platelets prevent blood loss through aggregation and interaction with clotting proteins. They are most commonly transfused to trauma victims and people undergoing chemotherapy.

"FDA approval for the InterSol® solution is an exciting milestone for Fenwal and represents our collaboration with customers, industry, and scientific leaders to introduce new ways to collect, process and store blood for transfusion," said William H. Cork, Fenwal senior vice president and chief technology officer. "This is one of several new products Fenwal plans to introduce that will help shape the practice of transfusion medicine."