New dialyzer approved by FDA
New dialyzer approved by FDA Stockholm, Sweden, November 8, 2000 - Gambro AB (OM Stockholm Exchange: GAMBaST, GAMBbST), a leading international medical technology and healthcare company, today announced that it has received approval by the US Food and Drug Administration, FDA, for a synthetic dialyzer for reuse applications. Initially, the dialyzer is primarily intended for Gambro's own clinics within Gambro Healthcare. It will rapidly replace external sourcing of reuse dialyzers and is part of Gambro's comprehensive expansion strategy in the field of dialyzers. The annual volume potential is more than one million dialyzers. For Gambro Healthcare this means a cost reduction and a treatment quality improvement. The dialyzer is Gambro's synthetic Polyflux filter which is the most advanced filter on the market for hemodialysis and convective treatments where the selection of membrane structure and polymer materials are of prime importance. Gambro's concept for Polyamide S - the membrane of the Polyflux S filter - results in unsurpassed removal capabilities in combination with superior biocompatibility. The structural arrangement of the Polyamide S membrane with its three layer design and microdomain surface resembles that of nature's own biological membrane. This means that the immune system and coagulation cascade is left practically unaffected by blood/membrane contact. Clinical experience provides evidence of significant treatment benefits that suggest a reduced need for medication and hospital care, increased overall patient well-being and improved quality of life. Gambro Renal Products Gambro has a global leading position in products and systems for renal care including hemodialysis, peritoneal dialysis and renal intensive care. Gambro Renal Products has annual sales of about USD 900 M and has about 6,000 employees. Products are marketed under the Gambro and Hospal brands and mainly include filters, machines, concentrates and bloodlines for dialysis. Products and services are sold in more than 90 countries including own sales organizations in 29 countries. Development of products and production technology is focused into product centers of excellence in Germany, Italy and Sweden. The global manufacturing organization includes sites in North America, Europe, Asia and Australia. Research is performed by groups covering the main areas biology, medicine, treatment systems, membranes and devices. Research groups are located in Germany, France and Sweden. For further information please contact: Bengt Modéer, Senior Vice President, Corporate Communications, tel. +46-8-613 65 00, +46-70-513 65 33 Cindy Lyman or Kerry Schneider, Citigate Dewe Rogerson, New York, tel. +1- 212-688 6840 ------------------------------------------------------------ This information was brought to you by BIT http://www.bit.se The following files are available for download: http://www.bit.se/bitonline/2000/11/08/20001108BIT00230/bit0001.doc http://www.bit.se/bitonline/2000/11/08/20001108BIT00230/bit0002.pdf