FDA grants new 510(k) clearance for Fenwal's Amicus blood cell separator

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 a new 510(k) clearance for its Amicus® blood cell separator.  

The new clearance involves the use of the Amicus® separator with InterSol® platelet additive solution, which Fenwal introduced earlier this year.  InterSol is an electrolyte-based fluid that replaces 65 percent of the human plasma previously needed as a storage solution for donated platelets.  Blood centers can collect the plasma replaced by InterSol and provide it to hospitals where it is used to treat patients.

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.

"This helps blood centers and hospitals realize the clinical and financial benefits of platelet collection using additive solution," said William H. Cork, Fenwal chief technology officer.  "At Fenwal, we are focused on delivering a series of innovations that continuously improve how blood is collected, separated, treated, stored and transfused for patients around the world."

In December 2009, the FDA called the approval of Fenwal's InterSol® solution "a significant step in the development and marketing of novel processes for the storage of platelets." Today, InterSol is the only platelet additive solution available in the United States, where more than 2 million platelet transfusions take place each year.

Platelets are given to patients to help prevent or stop bleeding.  They are needed by trauma victims and cancer patients undergoing chemotherapy.