Fenwal's new software release for Autopheresis-C system receives FDA 510(k) clearance

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 a new software release for its Autopheresis-C® system.  Blood and plasma centers worldwide use the Autopheresis-C system to collect plasma from donors.

The new software includes many new features designed to improve plasma collection for plasma- and blood-center professionals and donors.  The software helps automate and streamline collection processes, which reduce the need for operator intervention and help to improve work flow and reduce procedure times.  New confirmatory prompts are designed to make accurate programming for target plasma volumes even easier.

"The Autopheresis-C® system has long been an industry standard for collecting plasma of exceptional quality," said William H. Cork, chief technology officer for Fenwal.  "Our customers can now expect a series of innovations from Fenwal designed to make great instruments even better in terms of speed, ease of use and communications with plasma center information systems."

Plasma is the liquid portion of blood that contains valuable proteins used to treat burn victims, bleeding disorders, and for several therapeutic applications under development, such as for Alzheimer's disease, heart disease, and some cancers.  Plasma-derived proteins have become integral to many novel medical therapies in late-stage development.  Fenwal has established technical partnerships with pharmaceutical companies to assist them in this research and development.