A new solution for use with the Fenwal Amicus system to store donated blood platelets
FDA has granted approval to Fenwal to market its InterSol platelet additive solution. The InterSol solution is a specialised product used in combination with human plasma to store donated platelets, a vital blood component used to prevent or treat bleeding.
The company said that InterSol solution is approved for use 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% InterSol solution and 35% plasma.
The company said that in the US, platelets for transfusion are stored in 100% 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 company said that 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.
Karen Midthun, acting director of Center for Biologics Evaluation and Research at FDA, said: “The approval of InterSol is a significant step in the development and marketing of novel processes for the storage of platelets.”
William Cork, senior vice president and chief technology officer of Fenwal, said: “FDA approval for the InterSol solution is a 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. This is one of new products Fenwal plans to introduce that will shape the practice of transfusion medicine.”