HAEMONETICS ANNOUNCES EXPANDED FILTRATION CLAIMS FOR WHITE CELL REDUCTION.BRAINTREE, Mass.--(BUSINESS WIRE)--July 18, 1995--Haemonetics Corporation (NYSE NYSE See: New York Stock Exchange : HAE) announced that the Food and Drug Administration has granted premarket clearances for expanded labeling claims of two apheresis apheresis (əfĕr`əsĭs), or hemapheresis (hē'məfĕr`əsĭs), any procedure in which blood is drawn from a donor or patient and a component (platelets, plasma, or white blood disposable kits which allow Haemonetics blood bank customers to filter platelet products in-line to remove white cells (leukocytes). The FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. action allows Haemonetics customers using these disposables to label their products as Leukoreduced Platelets, Apheresis. This means that the collected blood products contain less than a maximum white cell count of 5x106, which meets the American Association of Blood Banks standards for leukocyte-reduced products. Haemonetics customers will also have a positive cost advantage because they will need only sample the leukocyte count for regularly scheduled quality control procedures and will no longer need to count the leukocytes in every product. During the past ten years, leukocyte-reduced blood products have played an increasing role in the management of a variety of transfusion-related adverse reactions and diseases. In the United States, approximately 20% of the blood products administered are leukocyte-reduced. Recently, filtration has been used increasingly for the preparation of leukocyte-reduced blood products. Compared to earlier methods, filtration offers the following advantages: removing at least 99% of the leukocytes while minimizing red blood cell red blood cell: see blood. or platelet loss, permitting product preparation in blood centers without additional preprocessing A preliminary processing of data in order to prepare it for the primary processing or for further analysis. The term can be applied to any first or preparatory processing stage when there are several steps required to prepare data for the user. steps, and providing products with full shelf life storage and probable improved clinical usefulness. John F. White, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Haemonetics stated, "We are pleased to offer our blood bank customers the opportunity to make a labeling claim about life saving platelet products collected by them which more accurately describes the value of the product transfused." Haemonetics is engaged in the design, manufacture and worldwide marketing of automated blood processing systems. The company's systems address three important medical markets: surgical blood salvage, blood component therapy blood component therapy Component therapy The therapeutic use of specific portions–components of blood–eg, factor VIII concentrates, packed red cells, or platelets rather than whole blood and automated plasma collection. CONTACT: Haemonetics Corp. Stephen P. Oliver (617) 356-9216 |
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