Navigation Links
Fenwal Receives FDA Approval for New Solution Used to Store Donated Blood Platelets
Date:12/15/2009

LAKE ZURICH, Ill., Dec. 15 /PRNewswire/ -- 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 approval to market InterSol® platelet additive solution. Fenwal® InterSol® solution is a specialized product used in combination with human plasma to store donated platelets, a vital blood component used to prevent or treat bleeding.

InterSol® solution is approved for use exclusively with platelets collected using the Fenwal® Amicus® separator, an advanced medical device that collects platelets and other blood components from eligible donors. The FDA approval will allow platelets to be stored in a mixture of 65 percent InterSol® solution and 35 percent plasma.

Traditionally, in the United States, platelets for transfusion are stored in 100-percent donated human plasma. The Fenwal® InterSol® solution replaces a portion of this plasma, which can then be used for other therapeutic purposes.

InterSol® solution is the only platelet additive solution to receive FDA approval. It has been used in Europe for several years.

"The approval of InterSol® is a significant step in the development and marketing of novel processes for the storage of platelets," said Karen Midthun, M.D., acting director of FDA's Center for Biologics Evaluation and Research, in an FDA news release.

InterSol® solution will be available for platelets collected with the Fenwal® Amicus® system, pending clearance of a 510(k) application under review by the FDA.

Platelets prevent blood loss through aggregation and interaction with clotting proteins. They are most commonly transfused to trauma victims and people undergoing chemotherapy.

"FDA approval for the InterSol® solution is an exciting milestone for Fenwal and represents our collaboration with customers, industry, and scientific leaders to introduce new ways to collect, process and store blood for transfusion," said William H. Cork, Fenwal senior vice president and chief technology officer. "This is one of several new products Fenwal plans to introduce that will help shape the practice of transfusion medicine."

About Fenwal

Fenwal, Inc. became an independent company in 2007, but its roots go back to 1949 with the founding of Fenwal Laboratories. Fenwal developed the first flexible, disposable container for blood collection, eliminating complications associated with glass containers and allowing blood to be separated into therapeutic components. Today, the company's products and advanced collection and separation technologies are used throughout the world to help ensure a safe and available supply of lifesaving blood and blood products. Fenwal Inc. is based in Lake Zurich, Illinois. For more information, please visit www.fenwalinc.com.

SOURCE Fenwal, Inc.


'/>"/>
SOURCE Fenwal, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. William Cork Joins Fenwal as Chief Technology Officer
2. EnzySurge Receives FDA Approval for SilverStream(TM) Innovative Wound Management Solution
3. Masimo Chairman and CEO Joe Kiani Receives 2009 Frost & Sullivan CEO of the Year Award
4. Transcept Pharmaceuticals Receives Notice of Allowance for Second U.S. Patent Application Covering Intermezzo(R)
5. Greenway Medical Technologies PrimeSuite 2011 Receives CCHIT 2011 Comprehensive Certification
6. Vion Pharmaceuticals Receives Complete Response Letter for Onrigin(TM) From The U.S. Food And Drug Administration
7. Mylan Receives Approval for Generic Version of Antiepileptic Keppra(R) 1000 mg
8. Dynatronics Receives 180-Day NASDAQ Extension
9. ARKRAY, Inc. Receives FDA 510k Clearance on the Assure(R) Platinum Auto-Code Blood Glucose Monitoring System
10. AdvanDx Receives FDA 510(k) Clearance for 90 Minutes PNA FISH(R) Protocol for Identifying Staphylococcal Bloodstream Pathogens
11. Masimo Receives 2009 Zenith Award at the American Association of Respiratory Care Congress
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/16/2017)... synthetic Fentanyl arrived on the streets in 2015, dealers were ... samples, inviting would-be customers to test a newly-created batch. They ... The rapidly-growing demand for the powerful ... has racked up a staggering death toll across ... fentanyl sales reveals that they have sold nearly 400 grams ...
(Date:1/16/2017)... , January 16, 2017 According to the new ... Multi Display , Smart Display, Graphic LCD Controller), Application (Industrial Control, ... published by MarketsandMakets, the market is expected to grow from USD 17.26 ... CAGR of 9.68% between 2016 and 2022. ... ...
(Date:1/16/2017)... Colo. , Jan. 16, 2017  Northern Colorado,s ... is bringing advanced laser treatments to Loveland ... clinic focuses solely on the removal of unwanted tattoos ... fading for tattoo cover-ups. "Tattoos are beautiful ... the way we hope they would," said Johnny ...
Breaking Medicine Technology:
(Date:1/15/2017)... ... January 15, 2017 , ... Whole Health Supply, LLC is announcing the release of ... also new avenues for purchase. , The 2017 edition has wide jaws that will ... the older boomers as well as diabetics. This handle is reinforced for extra strength when ...
(Date:1/15/2017)... ... January 15, 2017 , ... San ... in eight Bay Area counties for 2017. Almost 1,000 nominations were submitted and ... the award process. Results were announced the magazine’s January 2017 issue . ...
(Date:1/15/2017)... ... 2017 , ... The JPR Group, a public relations and ... will be assisting HackensackUMC Mountainside with its public relations efforts, effective January 2017. ... towns. The firm will be working closely with HackensackUMC Mountainside’s internal marketing operations. ...
(Date:1/14/2017)... ... , ... AgileMinder develops innovative products and services that bring "Care, Joy and ... Apple as a fun, free emoji sticker pack for iMessage. Use the stickers in ... coded values on The Emoji Scale. , On Apple: "The Emoji Scale by ...
(Date:1/13/2017)... Spain (PRWEB) , ... January 13, 2017 , ... The ... Melia Avenida America hotel on March 3-4, 2017. This Congress is expertly designed ... on the management of patients with lung cancer. , Chaired by Dr. Giorgio V. ...
Breaking Medicine News(10 mins):