Surgery, business  

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.

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