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Edge™ Radiosurgery Suite Receives FDA 510(k) Clearance For Non-Invasive Surgical Procedures

Medical Systems (NYSE: VAR) has received 510(k) clearance for the company’s Edge™ suite, a new dedicated system for performing advanced using innovative real-time tumor tracking and motion management technologies.

“The Edge suite represents a new paradigm in radiosurgery, offering clinicians a system that combines Varian’s world-class technologies in an end-to-end solution for planning and delivering radiosurgery treatments,” said Chris Toth, vice president of marketing for Varian’s Oncology Systems business.  “It integrates Varian’s state-of-the-art radiosurgery technology with tools for real-time imaging, tracking, and patient positioning.  It enables fast, accurate delivery of for treating lesions, tumors, and conditions anywhere in the body where radiotherapy is indicated, including tumors of the lung, prostate, spine and brain.” 

Recent FDA 510(k) clearances cover the following technologies that are integrated into the Edge .  These new technologies are also being made available as upgrades to other compatible Varian systems:

  • The PerfectPitch™ 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 PerfectPitch couch has been designed for the accuracy and functionality required to deliver radiosurgery treatments in the brain and in the rest of the body.
  • 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.  It also enables expanded use of fluoroscopy and 4-D cone-beam CT – imaging techniques that show motion over time – to better compensate for tumor motion during treatment.
  • Intracranial radiosurgery package: An integrated set of technologies for planning and delivering stereotactic radiosurgery treatments for tumors or functional abnormalities in the brain.  The intracranial radiosurgery package supports the accurate delivery of radiation using multiple beam shaping options, including Varian’s high-definition multileaf collimator and radiosurgery conical collimators, and is compatible with both frame-based and frameless patient immobilization approaches. 
  • 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® transponders for implantation in the lung to guide lung radiosurgery procedures. Note to editors: high resolution images of the EDGE radiosurgery suite are available here.


Source: Varian Medical Systems