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                                  ELEKTAS BEHANDLINGSSYSTEM FÖR LEKSELL GAMMA KNIFE® PERFEXION™ ERHÅLLER AMERIKANSKT MYNDIGHETSGODKÄNNANDE

                                  13 juli, 2006
                                  PRESSMEDDELANDE
                                  Stockholm den 13 juli 2006


                                  Den 5 juli meddelande den amerikanska hälsovårdsmyndigheten (U.S. Food and Drug Administration, FDA) att man lämnat ett så kallat 510(k)-godkännande för Leksell GammaPlan PFX, vilket är planerings- och behandlingssystem utvecklat för Leksell Gamma Knife Perfexion.

                                  I och med den pågående lanseringen av Leksell Gamma Knife Perfexion, utökar Elekta sin Leksell Gamma Knife® produktportfölj med ett helt nytt system. Detta system skapar en unik plattform som ytterligare expanderar tillämpningen av stereotaktisk strålkirurgi i hjärnan, övre ryggraden samt huvud/nacke. Ett 510(k)-godkännande avseende Leksell Gamma Knife Perfexion är att vänta från FDA.“Leksell GammaPlan PFX är en viktig del i Elektas helt nya plattform för stereotaktisk strålkirurgi, med ett enastående användargränssnitt som gör det möjligt att kunna dra full nytta av de nya innovativa funktionaliteterna på Leksell Gamma Knife Perfexion”, säger Vincent Denot, Produktchef för Leksell GammaPlan. “Ett 510(k)-godkännande från FDA är ett viktigt steg i Perfexion-projektet och ytterligare en milstolpe helt enligt tidsplanen”, avslutar Denot.******

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                                  Important Safety Information: Radiation therapy is not appropriate for all patients. Radiation treatments may cause side effects that can vary depending on the part of the body being treated. In some patients, they can be severe. Treatment sessions may vary in complexity and time. Refer to individual product labeling (instructions for use) for more complete information on product safety and effectiveness for its intended use.

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                                  Important Safety Information: Radiation therapy is not appropriate for all patients. Radiation treatments may cause side effects that can vary depending on the part of the body being treated. In some patients, they can be severe. Treatment sessions may vary in complexity and time. Refer to individual product labeling (instructions for use) for more complete information on product safety and effectiveness for its intended use.