Fenwal receives FDA marketing clearance for 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 510(k) clearance to market its Amicus® blood cell separator for collecting human platelets stored in InterSol® platelet additive solution (PAS 3).  Fenwal's InterSol® solution was approved by the FDA in December 2009 under a new drug application.  It is the first and only platelet additive solution now available in America.

In the United States, 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 percent InterSol® solution and 35 percent plasma.

In December, the FDA called approval of the Fenwal InterSol® solution "a significant step in the development and marketing of novel processes for the storage of platelets." With the new 510(k) clearance, InterSol® solution can now be used for the first time with an approved platelet-collection and storage system.

"We are working closely with the FDA and several blood centers on a post-market study of the InterSol® solution," said William H. Cork, Fenwal chief technology officer and senior vice president.  "Blood centers are eager to implement platelet additive solution, which we can now deliver. This is another important advance from Fenwal."

Platelets are transfused to help prevent or stop bleeding.  They are used to treat trauma victims and cancer patients undergoing chemotherapy.  More than 2 million platelet transfusions take place annually in the United States.

SOURCE Fenwal, Inc.