FDA clears Leksell Gamma Knife Perfexion
Elekta yesterday announced that the FDA issued a 510(k) pre-market clearance for Leksell Gamma Knife Perfexion, allowing Elekta to market this innovative new system for stereotactic radiosurgery in the United States.
The Gamma Knife product line stereotactic radiosurgery provides a platform for further refinement and expansion of radiosurgery procedures in the brain, cervical spine and head & neck regions, the company said.
Compared to earlier models, Leksell Gamma Knife Perfexion allows for increased treatable volume. The tool also is designed to decrease unwanted body dose to patient.
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 new features of Leksell Gamma Knife Perfexion. Leksell GammaPlan PFX received its U.S. FDA clearance in July.