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

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

PR Newswire

PALO ALTO, Calif., Jan. 24, 2013

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:

  oThe 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.

  oThe 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

  oIntracranial 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.

  oCalypso 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:

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 or follow
us on Twitter.


Varian Medical Systems
Meryl Ginsberg, 650.424.6444

SOURCE Varian Medical Systems

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