Pall Corporation (NYSE: PLL), a global leader in filtration, separation
and purification, today announced the launch of the Leukotrap® Affinity
Plus Prion and Leukocyte Reduction Filter System. The new blood filter
reduces prions and leukocytes in a single step. The Leukotrap® Affinity
Plus System is CE marked in accordance with requirements set out in the
Medical Devices Directive (93/42/EEC).
“We commend SaBTO for taking an important lead in securing the U.K.’s
blood supply from this devastating disease”
Infectious prions (PRPsc) are known to be the causative agent
of variant Creutzfeldt-Jakob disease (vCJD). The Pall Leukotrap Affinity
Plus System reduces PRPSC prion by >3 LOG on average, based
on Western blot methodology. As a primary leukocyte and prion reduction
technology, it also facilitates superior hemoglobin recovery, to meet
current EU requirements.
CE marking of the Pall Leukotrap Affinity Plus System supports new
guidance from the United Kingdom’s Advisory Committee on the Safety of
Blood, Tissues and Organs (SaBTO), which recently recommended
pre-transfusion filtration of red blood cells to remove prions, for
children born after January 1, 1996. The guidance, which is subject to
completion of clinical trials currently underway in Britain, is a
response to the incidence of vCJD in the wake of the bovine spongiform
encephalopathy (BSE) cases in Europe.
A human form of BSE, or Mad Cow Disease, vCJD is a fatal
neurodegenerative disease which can lie dormant for many years and for
which there is no cure. Since 1996, strong evidence has accumulated for
a causal relationship between outbreaks of BSE in cattle and vCJD in
humans. Since people can incubate vCJD with no clinical signs or
symptoms of disease for decades, there is no way to determine who or how
many people may be harboring the fatal prion nor how many of these
people may be blood donors. A single vCJD-infected blood donor has the
potential to amplify human-to-human transmission, creating the basis for
a far more widespread infection.
“We commend SaBTO for taking an important lead in securing the U.K.’s
blood supply from this devastating disease," said Eric Krasnoff, Pall
Chairman and CEO. "Pall's next generation Leukotrap® System reflects our
ongoing commitment to advancing blood safety and availability. It builds
on Pall’s legacy of innovation as the originator of leukocyte
filtration,” Mr. Krasnoff said. Introduced in the early 1990's, Pall's
leukoreduction filters are the global standard of care for transfusion
medicine.
Roberto Perez, President, Pall Life Sciences added, “Our goal is to help
blood centers and hospitals enhance their ability to provide patients
with access to the safest blood possible for transfusions. We do this by
developing innovative technologies that they can efficiently and
economically put into practice. This new product which simultaneously
accomplishes prion filtration and leukocyte reduction brings us another
step closer to this shared goal."
SOURCE Pall Corporation
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