Gambro BCT's platelet technology cleared by the US Food and Drug Administration for seven day storage (Local US press re

Gambro BCT's platelet technology cleared by the US Food and Drug Administration for seven day storage (Local US press release) Denver, CO October 20, 2003 - Gambro BCT, Inc., a wholly owned subsidiary of Gambro AB (Stockholmsbörsen: GAMBaST, GAMBbST), a leading international medical technology and healthcare company, today announced that platelets collected with its automated blood collection system, Trima®, and the blood components collection and separation system, Spectra(TM), can be stored safely and effectively for up to seven days. This is a significant increase over the previously approved five-day shelf life of platelets. Through in vitro and in vivo testing, Gambro BCT has demonstrated that its platelets are viable for patient transfu sions after storage of up to seven days, provided the platelets have been screened for bacteria by an approved method. Today, the greatest infectious disease risk associated with blood transfusion is fatal and non-fatal septic reactions from bacterially contaminated blood products. Stored at room temperature to retain their blood clotting capability, platelets are vulnerable to bacterial contamination. Because seriously ill patients, including those suffering from leukemia or cancer, receive platelet transfusions, any bacterial contamination can have serious consequences. Bacterial testing of platelet products prior to transfusion can reduce the risk of severe septic reactions in patients receiving platelets. Several European countries have already adopted 100% bacterial screening of platelets. In the US, the American Association of Blood Banks issued a new guideline in March 2003 recommending that all platelet products be tested for bacteria by March 1, 2004. The estimated total number of platelet units collected in 2003 is over 5.9 million. Of these, 2.7 million units are processed from whole blood, and 3.2 million units are collected through apheresis or automation. Implementation of 100% bacterial testing creates new challenges for blood centers. Currently available detection systems require a 24 to 48 hour quarantine of the platelets before release for transfusion. This reduction in useful shelf life may lead to unacceptably high outdate rates, adding cost and negatively affecting product availability. "The blood collection community is actively engaged in implementing appropriate actions to prevent and detect contaminating bacteria in platelets," according to Paul Ness, M.D., Professor of Pathology and Medicine, Johns Hopkins University and past president of the American Association of Blood Banks. "The ability to extend the shelf life of platelets from five to seven days is a major step which will facilitate the implementation of these safety measures while not compromising and perhaps improving the availability of this important therapeutic product," Dr. Ness said. "Single donor platelets produced by Gambro BCT systems and which are leukoreduced before storage using our unique LRS technology, are naturally suited for seven-day storage due to their low level of activation, the gas permeability of the storage bag, and proven in vivo platelet function," said David Perez, President of Gambro BCT. "Once bacterial screening methods are approved for use, seven-day platelets will improve not only the safety of the blood supply, but also the avail ability of platelets for transfusion," Mr. Perez added. Gambro BCT seven-day platelets can contribute to the evaluation and eventual implementation of bacterial testing because they are the first and only platelets cleared by the FDA and proven viable for the longer storage period. Gambro BCT is the industry leader in the collection of pre storage, leukoreduced platelets from a single donor. About Gambro BCT Gambro BCT is a wholly owned subsidiary of the Swedish medical technology and healthcare company, Gambro AB, and is headquartered in Lakewood, Colorado. Gambro BCT is a world leader in blood bank technologies: automated blood collection systems, automated component processing, pathogen reduction techniques, and value added blood and cell based therapeutic services. For further information please contact: David Perez, President, Gambro BCT, tel. +1-303-232-6800 Ellen Cohig, Marketing Communications Manager, Gambro BCT, tel. +1-303- 231-4145 or visit the website www.gambrobct.com ------------------------------------------------------------ This information was brought to you by Waymaker http://www.waymaker.net The following files are available for download: http://www.waymaker.net/bitonline/2003/10/20/20031020BIT00160/wkr0001.doc http://www.waymaker.net/bitonline/2003/10/20/20031020BIT00160/wkr0002.pdf

About Us

Gambro is a global medical technology and healthcare company with leading positions in renal care - services and products - and blood component technology. The group, with revenue of approximately SEK 18 billion (USD 2.2 billion), has approximately 17,000 employees in some 40 countries.

Subscribe