A blood cell separator that collects human platelets stored in an InterSol platelet additive solution has received 510(k) clearance from the US Food and Drug Administration (FDA).
The platelets collected by Fenwal's Amicus blood cell separator will be stored in a mixture of 65% InterSol solution and 35% plasma.
The InterSol solution, approved by the FDA in December 2009, 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.
For the first time, the InterSol solution can now be used with an approved platelet-collection and storage system.
Platelets are irregularly shaped, colourless bodies that are present in blood and help prevent or stop bleeding, and are also used to treat trauma victims and cancer patients undergoing chemotherapy.
