Pall launches Leukotrap Affinity Plus Prion and Leukocyte Reduction Filter System

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 (PRP^sc) are known to be the causative agent of variant Creutzfeldt-Jakob disease (vCJD). The Pall Leukotrap Affinity Plus System reduces PRP^SC 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."