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:5/6/2017)... Provista , a proven leader in the supply chain industry ... Jim Cunniff as the company,s new president and CEO. ... Provista, including most recently serving as the president and CEO ... He assumed his new role with Provista on May 1, ... says Jody Hatcher , president, Sourcing and Collaboration Services ...
(Date:5/6/2017)... 2017  Hill-Rom Holdings, Inc. (NYSE: HRC), has begun ... feet to its Welch Allyn campus. ... bring more than 100 new jobs to ... maintained a significant presence for more than 100 years. ... a large portion of which will be R&D and ...
(Date:5/4/2017)... May 4, 2017  A recent study published ... Ultraviolet-C light as a means of disinfection ... to reduce bioburden on anesthesia workstations. In the ... high-touch, complex medical equipment surfaces contaminated with three ... "This study further validates the body of ...
Breaking Medicine Technology:
(Date:5/26/2017)... YORK, NY (PRWEB) , ... May 26, 2017 ... ... Board (SAB) met this week to review more than eighty-nine grant submissions ... experienced and emerging young scientists in the Parkinson’s field.     , The American Parkinson ...
(Date:5/26/2017)... ... May 26, 2017 , ... A new analysis of ... the healthiest seniors are located in the Midwest. With the average cost of healthcare ... people are concerned with both the quality and affordability of where they live. An ...
(Date:5/26/2017)... ... 26, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House of ... on the Peace Agreements being discussed by President Donald Trump and the rest of ... try to speed up peace talks in the continuous battle between Israel and Palestine. ...
(Date:5/26/2017)... ... ... FLINTHILLS FAMILY-Our Journey to the Cross”: the personal journey of Bob Massey and his faith ... published authors, Bob and Margaret Massey. Bob Massey is small in stature but big ... tough." His love for others is apparent in all of his life decisions. ...
(Date:5/24/2017)... N.J. (PRWEB) , ... May 24, 2017 , ... ... Clara Maass Medical Center CEO Mary Ellen, hospital employees, and town officials to ... Belleville. , The facility was developed by Rendina as part of its ongoing ...
Breaking Medicine News(10 mins):