Navigation Links
FDA Clears the Fenwal Amicus(R) Separator System for Collecting Platelets in New Additive Solution
Date:3/8/2010

LAKE ZURICH, Ill., March 8 /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 510(k) clearance to market its Amicus® blood cell separator for collecting human platelets stored in InterSol® platelet additive solution (PAS 3).  Fenwal's InterSol® solution was approved by the FDA in December 2009 under a new drug application.  It is the first and only platelet additive solution now available in America.

In the United States, platelets for transfusion are currently stored in human plasma.  The InterSol® solution from Fenwal is an electrolyte-based formula that replaces a portion of this plasma, which can then be collected and used for other therapeutic purposes, such as treating burn victims.  The FDA clearance allows platelets collected using the Fenwal Amicus® separator system to be stored in a mixture of 65 percent InterSol® solution and 35 percent plasma.

In December, the FDA called approval of the Fenwal InterSol® solution "a significant step in the development and marketing of novel processes for the storage of platelets."(1)  With the new 510(k) clearance, InterSol® solution can now be used for the first time with an approved platelet-collection and storage system.

"We are working closely with the FDA and several blood centers on a post-market study of the InterSol® solution," said William H. Cork, Fenwal chief technology officer and senior vice president.  "Blood centers are eager to implement platelet additive solution, which we can now deliver. This is another important advance from Fenwal."

Platelets are transfused to help prevent or stop bleeding.  They are used to treat trauma victims and cancer patients undergoing chemotherapy.  More than 2 million platelet transfusions take place annually in the United States.

About Fenwal

Fenwal, Inc. is a global medical technology company focused on improving blood collection, filtration, separation, storage and transfusion to ensure the availability, safety and effectiveness of blood components.  Fenwal is unique in the depth of its experience and commitment to transfusion medicine.  The company offers the broadest range of products for the automated and manual collection of blood and blood components.  Fenwal became an independent company in 2007, but its roots go back to 1949 with the founding of Fenwal Laboratories.  Fenwal developed the first flexible, single-use 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 to help treat patients on six continents.  Fenwal, Inc. is based in Lake Zurich, Illinois.  For more information, please visit www.fenwalinc.com.

(1) FDA, 2009.  "FDA Approves First Additive Solution for Platelet Storage Up to 5 Days," United States Food and Drug Administration Press Release. [accessed: March 3, 2010] http://www.prnewswire.com/news-releases/fda-approves-first-additive-solution-for-platelet-storage-up-to-5-days-78971167.html.

SOURCE Fenwal, Inc.

Back to top

RELATED LINKS
http://www.fenwalinc.com

'/>"/>

SOURCE Fenwal, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Clears Advanced Test for Monitoring Metastatic Colorectal Cancer
2. FDA Clears ExAblate Fertility Enhancement Study in Women With Uterine Fibroids
3. FDA Clears the Pathwork(R) Tissue of Origin Test for Hard-To-Identify Tumors
4. U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of IDEV Technologies SUPERA Peripheral Stent
5. FDA Clears a Test for Ovarian Cancer
6. Private Investment Firm Czura Thornton Today Introduces Clearstone Central Laboratories as the Newest Member of the Czura Thornton Life Science Group
7. U.S. Food and Drug Administration Clears Alcatel-Lucent Remote Patient Monitoring Solution for Sale in the United States
8. FDA Clears the First Rapid Test to Detect Bacteria in Pooled Platelets
9. FDA Grants Cequent IND - Clears Way for First-Ever Clinical Trial of Orally Delivered RNAi Therapeutic: CEQ508, a tkRNAi Drug Candidate in Oncology
10. William Cork Joins Fenwal as Chief Technology Officer
11. Fenwal Responds to New Lawsuit From Haemonetics; Reiterates Commitment to Blood Centers
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2016)... ZIONA, Israel , May 4, ... TASE: BVXV) announced today that BiondVax,s CEO, Dr. Ron ... conference in New York City . ... at 10:30am at Pioneers 2016, a conference presented by ... York Palace Hotel. The BiondVax presentation that Dr. ...
(Date:5/4/2016)... 2016 Valeritas Holdings, Inc. (OTCQB: ... public offering (APO). This was accomplished via a reverse ... and a private placement of approximately 5 million shares ... Under the terms of the reverse merger, ... Inc. will trade on the OTC Markets under the ...
(Date:5/4/2016)... , May 4, 2016 ... addition of the  "Global Actinic Keratosis Market ... to their offering.       (Logo: ... Keratosis Market and Competitive Landscape Highlights 2016, ... products, Actinic Keratosis epidemiology, Actinic Keratosis market ...
Breaking Medicine Technology:
(Date:5/6/2016)... ... 06, 2016 , ... Multiple award winning plumbing company in San ... years. Maintaining core values of exceptional customer service, quality work at reasonable rates, and ... name in San Diego plumbing, and other services including heating & air conditioning and ...
(Date:5/6/2016)... Lowell, OR (PRWEB) , ... May 06, 2016 , ... ... moms, but for women everywhere. The 17th annual National Women’s Health Week ... and Office on Women’s Health are combining forces to empower women to make their ...
(Date:5/5/2016)... Aliso Viejo, CA (PRWEB) , ... May 05, 2016 , ... ... use in Final Cut Pro X. Drag and drop a TransWipe preset between two ... project. Choose from smooth corner wipes to colored panels with customizable color and orientation ...
(Date:5/5/2016)... , ... May 05, 2016 , ... Textile Exchange ... Wool Standard (RWS) for public stakeholder review. The stakeholder review is an important opportunity ... meets its goals and delivers value to the wool industry., The RWS is intended ...
(Date:5/5/2016)... ... 2016 , ... TLC Laser Eye Centers announced today that it has acquired ... now be called “Gordon Schanzlin New Vision Institute, a TLC Laser Eye Center.” ... to ensure that patients continue to receive the highest quality of care. In addition, ...
Breaking Medicine News(10 mins):