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FDA Clears Pall's New Leukocyte Reduction Filter For Improved Blood Processing Efficiency.


Business Editors/Health & Medical Writers

EAST HILLS, N.Y.--(BUSINESS WIRE)--Oct. 17, 2002

Pall Corporation (NYSE NYSE

See: New York Stock Exchange
: PLL PLL - phase-locked loop ) announced today that the U.S. Food and Drug Administration has granted approval to market a new leukocyte leukocyte (l`kəsīt'): see blood.
leukocyte
 or white blood cell or white corpuscle
 (white blood cell) reduction filter that processes blood faster and with greater improved plasma recovery.

Plasma is the critical source of life-saving drugs, such as Factor VIII for the management of hemophilia. The Pall RC2D Leukocyte Reduction Filter also allows blood centers to routinely process high volumes of red blood cells Red blood cells
Cells that carry hemoglobin (the molecule that transports oxygen) and help remove wastes from tissues throughout the body.

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red blood cells 
, even under extreme conditions such as hard-spun blood held for 72 hours in the cold, while providing consistent and reliable reduction of white blood cells White blood cells
A group of several cell types that occur in the bloodstream and are essential for a properly functioning immune system.

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.

"Leukocyte reduction of blood for transfusion is the standard of care around the world," said Samuel Wortham, President of Pall Medical. "The RC2D Leukocyte Reduction Filter comes at a time in blood banking when every drop counts. This new filter will enable blood banks to process more blood in less time while providing the safest blood for transfusion," he added.

The RC2D Leukocyte Reduction Filter is a new design that brings together Pall's unique Dual Disk technology and an innovative center flow manifold, enhancing flow and increasing the surface area over single sided filters by 50 percent. Filtration times are improved under a wide range of processing conditions for red cells produced at room temperature using hard and soft spins or within 72 hours cold storage. Red blood cell red blood cell: see blood.  recovery is greater than 90 percent. Plasma yields can increase by as much as 10 percent improving the efficiency of blood production without extended filtration time or filter plugging.

As with all of Pall's leukocyte reduction filters, the RC2D filter produces blood products that consistently attain an extremely low level of residual leukocytes (3 to 10 x 104 cells per unit), well below established standards. It is incorporated into Pall's Leukotrap(R) RC inline blood processing systems, which easily fits into blood bank standard operating procedures, providing the highest assurance of GMP GMP (guanosine monophosphate): see guanine.  compliance.

Currently 65% percent of the U.S. blood supply is filtered to reduce contaminating donor white blood cells. Last year, the U. S. Department of Health and Human Services Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979
Health and Human Services, HHS
 Advisory Committee on Blood Safety and Availability recommended implementation of universal leukocyte reduction as soon as feasible. Clinical studies have shown that filtering out white blood cells reduces a wide variety of adverse transfusion reactions including non-hemolytic febrile febrile /feb·rile/ (feb´ril) pertaining to or characterized by fever.

feb·rile
adj.
Of, relating to, or characterized by fever; feverish.
 transfusion reactions, alloimmunization, transmission of pathogens such as cytomegalovirus (CMV), and suppression of the immune system. Based on medical risk and clinical benefits of filtration, hospitals and blood centers in 23 countries now routinely filter all blood or are moving toward this as a goal.

About Pall Corporation

Pall Corporation is the global leader in the rapidly growing field of filtration, separations and purification. Pall's business is organized around two broad markets: Life Sciences and Industrial. The Company provides leading-edge products to meet the demanding needs of customers in biotechnology, pharmaceuticals, transfusion medicine, semiconductors, municipal drinking water and aerospace. Pall Medical, part of the Company's Life Sciences segment, is the worldwide leader in leukocyte reduction filtration technologies for both red blood cells and platelets. The Company is involved in extensive research and development in many areas of blood safety. Total revenues for Pall Corporation are $1.3 billion. The company is headquartered in East Hills, New York East Hills is a village in Nassau County, New York on the North Shore of Long Island. It is considered part of the Greater Roslyn area, which is anchored by the Village of Roslyn. As of the United States 2000 Census, the village population was 6,842. , and has operations in more than 30 countries. Further information can be found on its Web site (www.pall.com).
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Oct 17, 2002
Words:578
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