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PRESS RELEASE Stockholm, Sweden, July 13, 2006 On July 5, the U.S. Federal Drug Administration (FDA) announced a 510(k) pre-market clearance for Leksell GammaPlan® PFX™, the treatment planning system developed for Leksell Gamma Knife® Perfexion™.
By the ongoing market introduction of Leksell Gamma Knife Perfexion, Elekta expands the Leksell Gamma Knife® product line with a completely new system that takes stereotactic radiosurgery to the next level and provides a radiosurgical platform for further refinement and expansion of procedures in the brain, cervical spine and head & neck regions. Leksell Gamma Knife Perfexion is pending 510(k) clearance from the FDA.
“Leksell GammaPlan PFX is a vital part of Elekta’s brand new platform for stereotactic radiosurgery, providing unmatched ease-of-use and reaping the benefits of the highly innovative design of Leksell Gamma Knife Perfexion”, says Vincent Denot, Elekta’s Product Manager for Leksell GammaPlan. “This 510(k) pre-market clearance from FDA is an important milestone in the Perfexion project and yet another such event that is occurring exactly according to plan”, Denot concludes.