Source: Pall
Corporation
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Posted: 11
Oct, 2004
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Kawasumi To Market Pall's
eBDS in Japan
Pall Corporation have announced that it has
finalized an agreement for Kawasumi Laboratories, Inc. to become the exclusive
provider of the Pall eBDS (enhanced Bacterial Detection System) in Japan.
Bacterial contamination of platelets is the number one infectious cause of
morbidity and mortality from a blood transfusion. Bacteria contaminate anywhere
from one in 2,000 to one in 5,000 platelets collected worldwide. The number of
platelet collections in Japan is about 780,000 annually. This agreement is the
latest in a ten-year long relationship between the two companies. Kawasumi, a
leading provider of medical devices and pharmaceuticals for blood banking, uses
only Pall leukocyte (white blood cell) reduction filters in its blood
collection and transfusion systems and is Palls exclusive route to market
for these filters in such systems in Japan.
Under the new agreement, Pall is also receiving milestone payments to
correspond with providing Kawasumi scientific and technical support to help it
bring the technology to market in Japan. Kawasumi will submit the product to
the Japanese regulatory authority (MoHLW), whose approval process often mirrors
that of the U.S. Food and Drug Administration (FDA). The FDA cleared the Pall
eBDS for marketing in January 2004. The eBDS is also approved by Health Canada,
the Canadian regulatory authority, and is CE marked for use throughout Europe.
More than 30 U.S. blood centers, one of Canadas largest hospitals, plus
four blood centers throughout Europe and the Middle East have already
incorporated the Pall eBDS as part of their routine standard of practice.
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