PRESS RELEASE Stockholm, Sweden, August 23, 2006 On Monday, August 21, the U.S. Food and Drug Administration (FDA) issued a 510(k) pre-market clearance for Leksell Gamma Knife® Perfexion™, allowing Elekta to market this innovative new system for stereotactic radiosurgery also on the U.S. market.
With Leksell Gamma Knife Perfexion, Elekta expands the Gamma Knife® product line with a completely new system that takes stereotactic radiosurgery to the next level and provides a platform for further refinement and expansion of radiosurgery procedures in the brain, cervical spine and head & neck regions.
Compared to earlier models, Leksell Gamma Knife Perfexion allows for a dramatically increased treatable volume. Subsequently, this new system is estimated to increase the number of patients that can benefit from Gamma Knife® surgery by up to 40 per cent, while maintaining full clinical compatibility with Gamma Knife procedures and protocols based on nearly 400,000 treated patients. The fully automated and efficient single push button approach is expected to save 3-5 working weeks of physician time per year at an average Gamma Knife center.
Designed from the ground up with patient and staff comfort in mind, the unwanted body dose to patient is up to 100 times less with Leksell Gamma Knife Perfexion, compared with competing technologies, important not least for pediatric treatment and treatment of women of childbearing age.
The new system also comes with Leksell GammaPlan® PFX™, a new client-based treatment planning system with remote capabilities which provides all the tools needed to make full use of the sophistication and new features of Leksell Gamma Knife Perfexion. Leksell GammaPlan® PFX™ received its US FDA clearance in July, 2006.
“We are very pleased with the FDA clearance after a shorter than expected process. Leksell Gamma Knife Perfexion has been met with very strong interest from neurosurgeons and radiation oncologists from all over the world and not least in the United States. These current and future Gamma Knife users are impressed with the expanded clinical applications, flexibility, ease of use and workflow enhancement of this revolutionary new system for stereotactic radiosurgery,” says Tomas Puusepp, President and CEO of Elekta and concludes; this is an important step in the launch of Leksell Gamma Knife Perfexion, allowing us initiate marketing and to start signing orders on this important market.