Varian Medical Systems Receives FDA 510(k) Clearance for the Edge Radiosurgery Suite for Non-Invasive Surgical Procedures

Thu Jan 24, 2013 8:01am EST

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PALO ALTO, Calif.,  Jan. 24, 2013  /PRNewswire/ -- Varian Medical Systems (NYSE:
VAR) has received FDA 510(k) clearance for the company's Edge radiosurgery
suite, a new dedicated system for performing advanced radiosurgery 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 stereotactic radiosurgery 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 radiosurgery suite.  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 at this URL: 
http://varian.mediaroom.com/image-gallery?mode=gallery&cat=2874.  

About Varian Medical Systems
Varian Medical Systems, Inc., of  Palo Alto, California, is the world's leading
manufacturer of medical devices and software for treating cancer and other
medical conditions with radiotherapy, radiosurgery, and brachytherapy. The
company supplies informatics software for managing comprehensive cancer clinics,
radiotherapy centers and medical oncology practices. Varian is a premier
supplier of tubes, digital detectors, and image processing workstations for
X-ray imaging in medical, scientific, and industrial applications and also
supplies high-energy X-ray devices for cargo screening and non-destructive
testing applications.  Varian Medical Systems employs approximately 6,200 people
who are located at manufacturing sites in  North America,  Europe, and  China 
and approximately 70 sales and support offices around the world. For more
information, visit  http://www.varian.com  or follow us on  Twitter.  

FOR INFORMATION CONTACT:  

Varian Medical Systems
Meryl Ginsberg, 650.424.6444  
meryl.ginsberg@varian.com

SOURCE  Varian Medical Systems

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