Fenwal Receives CE Mark Approval for Therapeutic Plasma Exchange on Its Amicus® System

New protocol expands therapeutic applications for Fenwal technology

LAKE ZURICH, Ill. - Thursday, June 16th 2011 [ME NewsWire]

(BUSINESS WIRE)-- Fenwal, Inc., a global medical technology company focused on improving blood collection, separation, safety and availability, announced today it has received CE Mark approval for a therapeutic plasma exchange protocol for the company’s Amicus® system.

Therapeutic plasma exchange, or TPE, removes substances from blood that can cause or complicate disease and is used in the treatment of a wide range of hematologic, neurologic, autoimmune, and kidney disorders. CE Mark approval allows Fenwal to market its Amicus® system for TPE in Europe.

The addition of a TPE protocol makes the Amicus® system an even more versatile technology for hospitals and blood centers. Fenwal’s Amicus® system is used today throughout the world to collect platelets, platelets with concurrent plasma and red cells, and mononuclear cells used for therapeutic applications and clinical research.

“The Amicus system with platelet and mononuclear cell collection, and now with TPE, offers medical professionals a unique and versatile solution for helping to treat a wide variety of diseases and conditions,” said William H. Cork, chief technology officer for Fenwal. “We continue to expand our offerings in blood technologies to help make blood therapies better and to create more value for blood centers, hospitals and other sites of care.”

The Amicus® system with TPE is an advanced cell separation system that uses a disposable collection set to draw blood from patients for automatic, chair-side separation to remove the plasma containing harmful substances, and return to the patient his or her own red cells, platelets and a plasma-replacement solution made up saline, human albumin and other components. The continuous-flow TPE procedure on the Amicus system is designed to be efficient with minimal operator intervention.

About Fenwal

Fenwal, Inc. is a global medical technology company dedicated to ensuring the continued availability, safety and effectiveness of blood – medicine’s most vital natural resource. Fenwal offers a wide range of products for the automated and manual collection, filtration, separation, storage and transfusion of blood and its components. The company was founded in 1949. Today, Fenwal products and advanced blood technologies are used to help treat patients on six continents. Fenwal, Inc. is based in Lake Zurich, Illinois. For more information, please visit www.fenwalinc.com.

Contacts

Fenwal, Inc.

Tanya Tyska, 847.550.2732

tanya.tyska@fenwalinc.com