FDA grants Fenwal 510(k) clearance for ALYX blood component collection system with wireless data export

Fenwal, Inc., a global medical technology company focused on improving blood collection, separation, safety and availability, announced today the U.S. Food and Drug Administration has granted Fenwal 510(k) clearance to market its ALYX™ component collection system with new wireless data export capabilities.

The ALYX system is a mobile blood component collection device used primarily to collect red blood cells.  The system can collect two units of red cells from a single donor in less than 30 minutes.  

The addition of wireless data export allows blood collection professionals to electronically access detailed information about donation procedures on mobile and fixed-site blood drives.  These data can then be used to track and improve blood center performance and enhance the donation experience for donors and collectors.

When accompanied by the Fenwal data exchange system, scheduled for release in the first half of 2011, data export will allow centers to create customized reports with procedure and other data from the ALYX system.  Blood centers can use these data to identify training opportunities designed to enhance operator and system performance.

Fenwal is unique in offering data export capabilities designed for open-source compatibility with blood and plasma center information systems.  Earlier this year Fenwal received FDA clearance for wireless data export on the Fenwal AMICUS™ system, which is used to collect platelets, and the Fenwal AUTOPHERESIS-C™ system, which collects plasma.  

"In providing data export for apheresis systems, our objective is to help the professionals who collect blood and plasma to improve how they work, optimizing their productivity and offering a positive experience for donors," said William H. Cork, chief technology officer for Fenwal.  "Blood collectors are vital to the nation's blood supply and Fenwal is dedicated to supporting their mission.  Since ALYX is a mobile collection system used in many different settings outside blood centers, wireless capability is helpful to transmit information about mobile collection, allowing centers to gain new insight into their efficiency on mobile blood drives."