Varian Medical Systems, Inc. has received FDA 510(k) clearance for the company's Edge(TM) radiosurgery suite, a new dedicated system for performing advanced radiosurgery using innovative real-time tumor tracking and motion management technologies. Recent FDA 510(k) clearances cover the following technologies that are integrated into the Edge radiosurgery suite. These new technologies are also being made available as upgrades to other compatible Varian systems: The PerfectPitch(TM) couch: An integrated six degrees of freedom (6DoF) treatment couch that provides the accuracy, precision, and flexibility needed to position patients optimally, adjust their position to correct for any misalignments, and support them comfortably during treatment.

The Advanced Motion & Image-Guided Radiotherapy (IGRT) package: An advanced motion management package that offers clinicians many options for using real-time imaging during radiotherapy treatments. Intracranial radiosurgery package: An integrated set of technologies for planning and delivering stereotactic radiosurgery treatments for tumors or functional abnormalities in the brain. Calypso system: Several enhancements have been incorporated into the Calypso system for real time tracking.

The system utilizes transponders, or position signaling devices, that are implanted in or around a tumor, or placed on the surface of the body and monitored to track motion during treatment. New enhancements increase the rate of transponder signal processing in order to track faster types of motion, such as respiratory motion, in real time. The system is also compatible with the couch rotations that are often used to optimize targeting during treatments in the lung.

The new system also includes updated usability features designed to streamline treatments and enhance the user experience. One optional Edge suite subcomponent is still pending FDA 510(k) clearance: Calypso anchored Beacon(R) transponders for implantation in the lung to guide lung radiosurgery procedures.