Gambro receives US 510(k) approval for new dialyzer for treatment of renal failure
Gambro receives US 510(k) approval for new dialyzer for treatment of renal failure Stockholm, Sweden, July 8, 2003 Gambro AB (Stockholmsbörsen: GAMBaST, GAMBbST), a leading international medical technology and healthcare company, today announced that Gambro Renal Products in the United States has received FDA clearance of the 510(k) Notification for the Polyflux® LR Hemodialyzer. This is the newest member of its Polyflux hemodialyzer product line, used for the treatment of chronic and acute renal failure. The Polyflux LR may be reprocessed for reuse on the same patient. "Responding to our customers' demand for a high efficiency, low flux, reuse dialyzer, Gambro Renal Products continues to provide exceptional medical devices for renal failure patients", said Len Braganza, President Gambro Renal Products, U.S. "We are extremely excited about the newest member of the Polyflux family. The Polyflux LR dialyzer, not only extends a legendary line of Gambro dialyzer products, but completes the variety of Gambro dialyzers offered to healthcare professionals for all hemodialysis patients." Polyflux LR features Gambro's exclusive membrane technology of a three- layer microstructure which offers maximum permeability for uremic toxins removal and a protective barrier against the risk of loosing proteins or infusing endotoxins. The Polyflux membrane offers the distinct attributes of minimal thrombogenic events, a stable sieving coefficient, predictable dialysis dose (Kt/V), and outstanding biocompatibility with low complement activation. Additionally, the membrane brings about easy priming, negligible protein adhesion, and excellent rinse-back. For further information please contact: Bengt Modéer, Senior Vice President, Corporate Communications, tel. +46-8-613 65 33, +46-70-513 65 33 Pia Irell, Investor Relations Director, Corporate Finance, tel. +46-8-613 65 91, +46-70-513 65 91 Kevin Smith, President Gambro Inc., Investor Relations US, tel. +1-303 231 4750 ------------------------------------------------------------ This information was brought to you by Waymaker http://www.waymaker.net The following files are available for download: http://www.waymaker.net/bitonline/2003/08/11/20030708BIT00220/wkr0001.doc http://www.waymaker.net/bitonline/2003/08/11/20030708BIT00220/wkr0002.pdf