Elekta (STO:EKTA B) has recently been granted USFDA 510(k) pre-market clearance for Leksell Gamma Knife® Perfexion™, allowing the company to market this innovative new system for stereotactic radiosurgery also on the U.S. market.

Elekta's Leksell Gamma Knife® Perfexion™ 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.

Leksell Gamma Knife® Perfexion™ allows for a dramatically increased treatable volume. Compared to its earlier models, this new system is estimated to increase the number of patients that can benefit from Gamma Knife® surgery by up to 40 %, while maintaining full clinical compatibility with Gamma Knife® procedures and protocols based on nearly 400,000 treated patients.

Leksell Gamma Knife® Perfexion™ is a fully automated and efficient single push button approach expected to save 3-5 working weeks of physician time per year at an average Gamma Knife® center.

According to Tomas Puusepp, President and CEO of Elekta:

"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.

This is an important step in the launch of Leksell Gamma Knife® Perfexion™, allowing us to initiate marketing and to start signing orders on this important market."

Read the full press release.