FDA grants Fenwal 510(k) clearance for Amicus separator with DXT

Fenwal, Inc. (www.fenwalinc.com), 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 for its Amicus® separator with new wireless data-export capabilities.  

The Fenwal Amicus® separator is an advanced medical device used to collect platelets and other blood components from donors.  The addition of wireless data management allows blood centers to easily access procedure information to monitor machine and operator performance without the added cost or capital investment of rewiring facilities.

During customer trials, blood centers reported that the Amicus® separator with DXT helped them increase platelet yield per donor by enabling better analysis of performance by device, operator and collection site.  

Amicus® separators with DXT offer blood-center professionals easy-to-read, on-demand reports concerning donations at multiple locations.  These reports help identify opportunities for improvement and training.

"With Amicus® DXT from Fenwal we increased our platelet split rate 23 percentage points," said Karen Nielsen, M.B.A., MT(ASCP)SBB, blood services group manager of ARUP Blood Services, one of the largest blood collectors in Utah. "The technology and data-analysis reports have helped our staff measure and improve our performance and productivity and helped to assure platelets are available for critical therapies." By collecting and splitting a large platelet product from eligible donors, blood centers can obtain two or more therapeutic doses from a single platelet donation. 

Fenwal DXT technology features open-source compatibility, enabling connection to virtually any blood-center information system.  It can also generate reports using proprietary templates offered by Fenwal, or via commercially available tools such as Crystal Reports.  Fenwal plans to add wireless functionality to its other automated blood collection and separation systems.

"Fenwal's data management strategy is designed to deliver what blood centers say they want most—a simple, open-ended solution that allows them to securely capture and analyze procedure data from different locations without having to make a big investment in multiple systems and training," said William H. Cork, Fenwal chief technology officer and senior vice president.  "Blood centers, like many other companies, want to automate data collection to optimize operations, address training needs and improve documentation.  We are pleased to introduce this customer-focused innovation for use with our popular Amicus® separator."

The Amicus® separator with DXT uses barcode scanners to capture kit lot numbers, operator ID and donation ID for each collection procedure.  The information is then sent through a secure wireless connection from the Amicus® separator to a server connected through the blood center's network.  Standard reports analyze procedure data by operator and by device, with data typically available within minutes of a completed procedure.  

Amicus® separator with DXT is one of several recent advancements for the Amicus® separator.  Earlier this year, Fenwal received FDA clearance to market the Amicus® separator for collecting platelets stored in Fenwal InterSol® platelet additive solution, the first and only platelet additive solution available in the United States.