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May 25, 2015 12:00 PM ET

Healthcare Equipment and Supplies

Company Overview of Fenwal Inc.

Company Overview

Fenwal Inc. develops products for transfusion medicine and cell therapies. The company offers various products and services, which focuses on apheresis collections, therapeutic procedures, and manual collection processes. It offers component collection and processing systems including Amicus, a system that collects mononuclear cells, therapeutic plasma, and RBCs; Alyx, a mobile and multi-component collection, processing, and leuko-filtration system; Autopheresis-C and Aurora, an automated system that streamlines plasma collection and produces virtually cell-free plasma for operators and donors; and InterSol, a platelet additive solution. The company also provides blood collection units with ...

Three Corporate Drive

Lake Zurich, IL 60047

United States

Founded in 1949

Phone:

847-550-5689

Fax:

847-550-2960

Key Executives for Fenwal Inc.

Chief Financial Officer and Senior Vice President
Chief Executive Officer of Fresenius Kabi Region North America and President of Fresenius Kabi Region North America
President of Medical Devices for Fresenius Kabi North America
Chief Technology Officer and Senior Vice President
Age: 54
Chief Information Officer and Senior Vice President
Compensation as of Fiscal Year 2014.

Fenwal Inc. Key Developments

Fenwal Receives FDA Clearance to Include New Clinical Data in the Product Label of its Platelet Additive Solution, InterSol

Fenwal announced it has received FDA clearance to include new clinical data in the product label of its platelet additive solution, InterSol(TM) (PAS 3). A multi-center, non-randomized, open-label retrospective medical chart review study involving about 14,000 transfusions looked at adverse events related to platelet transfusion with and without additive solution. Platelet transfusions using Fenwal InterSol led to a 0.55% adverse event reaction rate, while transfusions using only plasma platelets led to a 1.37% adverse event reaction rate. Clinical experience has suggested that allergic transfusion reactions may be reduced by replacing a portion of the total plasma volume with platelet additive solution. Fenwal InterSol solution replaces approximately 65% of the plasma used for platelet storage, on platelets collected on the Fenwal Amicus(R) separator. The results of this study are consistent with these previous findings. No adverse safety trends were identified after a review of all the adverse events by the Independent Clinical Events Committee. Platelet transfusions using Fenwal InterSol resulted in a 0.29% allergic reaction rate, while transfusions using only plasma platelets resulted in a 0.82% allergic reaction rate. Febrile Non-Hemolytic Transfusions reaction events were associated with 0.17% of platelet transfusions with Fenwal's InterSol and 0.50% of transfusions with plasma platelets.

Fenwal, Inc. Receives FDA 510(K) Clearance for the Alyx System Software Version 3.1

Fenwal Inc. announced it has received FDA 510(k) clearance for the Alyx(R) system software version 3.1. The new software gives the Alyx system a protocol for closed system plasma collection and expanded data management capabilities. The Alyx system now includes three procedures to help customers meet their collections needs: two units of red blood cells, one unit of red blood cells with plasma, and plasma alone. The Alyx system is used worldwide to collect life-saving blood components for patient transfusion. Plasma collected on the Alyx system can be processed as Fresh Frozen Plasma (FFP), Plasma Frozen within 24 hours of collection (PF24) or Plasma Frozen within 24 hours of collection held at Room Temperature for 24 hours (PF24RT24). The new Alyx system software supports remote procedure setup and paperless documentation when used with the Fenwal DXT(R) Relay data exchange software and a blood center's blood establishment computer system (BECS). With remote procedure setup, donor registration information may be entered remotely into an Alyx instrument. This helps assure data accuracy, documentation compliance, and streamlines processes. The DXT(R) Relay software also provides blood center professionals with easy-to-read, on-demand reports that consolidate procedure data from multiple Alyx systems in different locations. The reports track performance indicators and may be used to identify opportunities for operational improvement and training. The DXT(R) Relay software was built with open architecture so it is integrated seamlessly with existing blood center systems. Once integrated with a center's BECS, DXT Relay can provide data that will meet regulatory requirements for paperless documentation. Plasma is the liquid portion of blood that contains valuable proteins used to treat burn victims, bleeding disorders, human immune deficiencies and other chronic or genetic disorders. Unlike other blood components, which are stored at room temperature or refrigerated, plasma is frozen and thawed prior to fractionation or transfusion.

Fenwal Receives 60601-1 3rd Edition Certification for Aurora plasmapheresis System

Fenwal announced that it has received 60601-1 3rd edition certification for the Aurora plasmapheresis system designed for collection of plasma. 60601-1 3rd edition is the latest international consensus standard representing the current "state of the art" for medical device design and allows Fenwal to market the Aurora system in Europe. The Aurora system continues to use the company's proven and proprietary filtration separation method which enables the collection of virtually cell-free plasma and meets European requirements without further filtration. The Aurora system offers new features that improve work flow and help ensure a successful collection. Intuitive on-screen instructions simplify training for operators and provide troubleshooting assistance. An LCD display allows donors themselves to see how their donation is progressing. The Aurora system can support remote procedure set up and paperless documentation when used with the Fenwal DXT Relay software and a plasma center's donor management system. With remote procedure set up, the Aurora system can be programmed automatically based on donor registration information. These features help assure data accuracy, documentation compliance, and a more streamlined procedure. The Fenwal DXT Relay software also provides plasma center professionals with easy-to-read, on-demand reports that consolidate donor and procedure data from multiple Aurora systems at different locations. The reports track specific performance indicators and can be used to identify opportunities for operational improvement and training. The Fenwal DXT Relay software was built with open architecture so that it can seamlessly integrate with existing plasma center systems without requiring expensive, proprietary add-ons.

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