East Hills, NY (October 5, 2005) - - Pall Corporation (NYSE: PLL) announced today FDA clearance to market the new Pall Acrodose? PL System. This is the first whole blood derived platelet system for pre-storage pooling and testing of leukoreduced whole blood derived platelets resulting in a transfusion-ready product for the hospital. This unique product increases the availability of lifesaving platelets, enhances patient safety and is more cost-effective for the hospital.
"Adequate platelet availability in some communities can sometimes be a challenge," says Allan Ross, President of Pall Medical. "The Acrodose PL System provides an opportunity for blood centers and hospitals to increase the availability of bacterially tested, leukoreduced, and pooled whole blood derived platelets in a cost-effective manner."
Platelets are derived from donors in either a one-to-two hour procedure called apheresis or from standard whole blood collections. Apheresed platelets are limited by donor availability. They are also time consuming and capital intensive to obtain. Regardless of which collection process is used, bacterial contamination of platelets is the leading infectious cause of illness and death from a blood transfusion. Single donor platelets are tested for bacterial contamination using a sensitive culture detection method such as Pall's eBDS, enhanced bacterial system. Whole blood derived platelet units on the other hand are tested using less sensitive methods due to cost, product loss, and logistical constraints of testing several individual units to obtain a standard therapeutic dose. This has resulted in a disparity of test sensitivities as well as underutilization of a valuable blood resource.
The new Acrodose PL System enables blood centers to pool individual whole blood derived platelets prior to storage and conduct a single bacterial contamination test with its integrated Pall eBDS technology. Studies using the Pall eBDS System with pooled platelets resulted in greater than 99 percent detection of bacteria that can contaminate platelets. With the new Acrodose PL System, blood centers will be able to provide hospitals and transfusion services with AcrodoseSM Platelets, a transfusion-ready therapeutic dose of platelets that is both leukoreduced and bacteria tested with a highly sensitive culture based method. In turn, hospitals can reduce their handling costs by eliminating the need for further processing and testing.
"This is a seminal advance in blood safety and availability because hospitals now have assurance of access to more platelets that are safer than currently available whole blood derived platelets," says Roslyn Yomtovian, MD, Professor, Department of Pathology, Case Western Reserve University School of Medicine, Cleveland, Ohio.
There are approximately 2.1 million transfusions annually in the U.S alone. On average, platelets are outdated and thrown away in five days making access to this lifesaving blood product precarious and costly, and especially problematic in emergency situations.
Several studies on the value of pre-storaged pooled platelets will be presented at the upcoming AABB annual meeting in Seattle, Washington as follows: Washington State Convention and Trade Center, October 16, 2005 starting at 2:15 pm
Susan L. Wilkinson, EdD, Associate Director and Associate Professor Hoxworth Blood Center University of Cincinnati Medical Center
Laura Cooling, MD MS, Assistant Professor, Department of Pathology, Associate Medical Director, Transfusion Medicine, University of Michigan
Scott Murphy, MD, Medical Director, American Red Cross, Penn Jersey Division
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