Elekta receives FDA clearance for stereotactic radiosurgery system
30 August 2006
Stockholm, Sweden. Elekta has received US FDA 510(k)
pre-market clearance to market its Leksell Gamma Knife Perfexion
stereotactic radiosurgery system in the U.S.
"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. "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.
The new system is estimated to increase the number of patients that
can benefit from Gamma Knife surgery by up to 40%, compared to previous
models, while maintaining full clinical compatibility with Gamma Knife
procedures and protocols based on nearly 400,000 treated patients. The
fully automated system is expected to save 3-5 working weeks of
physician time per year at an average Gamma Knife centre.