Fenwal, Inc. (Lake Zurich, Illinois) has announced 510(k) clearance for use of the company’s Amicus separator with the new InterSol platelet additive. InterSol can take the place of plasma, which is currently used as a storage medium for platelets collected from donated blood. This frees up additional plasma for hospital use without requiring an increase in blood donations.
From the press release:
While practices vary at blood centers, healthy donors may donate platelets as often as once a week, but no more than 24 times in a 12-month period. In granting the new 510(k) clearance, the FDA has approved an addition to Fenwal labeling that defines specific conditions under which the volume of plasma replaced by InterSol® solution may be collected without increasing the donor deferral period.