Fenwal, a medical technology company, has received FDA 510(k) clearance to market its Amicus blood cell separator for collecting human platelets stored in InterSol platelet additive solution (PAS 3).
Fenwal said that its InterSol solution has been approved by the FDA in December 2009 under a new drug application. It is the platelet additive solution available in America.
In the US, platelets for transfusion are currently stored in human plasma. The InterSol solution from Fenwal is an electrolyte-based formula that replaces a portion of this plasma, which can then be collected and used for other therapeutic purposes, such as treating burn victims. The FDA clearance allows platelets collected using the Fenwal Amicus separator system to be stored in a mixture of 65% InterSol solution and 35% plasma.
The company said that with this new 510(k) clearance, InterSol solution can be used for the first time with an approved platelet-collection and storage system.
William Cork, chief technology officer and senior vice president of Fenwal, said: “We are working closely with the FDA and several blood centers on a post-market study of the InterSol solution. Blood centers are eager to implement platelet additive solution, which we can now deliver. This is another important advance from Fenwal.”