Varian Medical Systems Receives FDA 510(k) Clearance for Vitesse™ Brachytherapy Treatment Planning Software

      Varian Medical Systems Receives FDA 510(k) Clearance for Vitesse™
                  Brachytherapy Treatment Planning Software

Tool enables clinicians to plan and perform high-dose-rate (HDR) brachytherapy
treatments for prostate cancer using real-time ultrasound guidance

PR Newswire

PALO ALTO, Calif., Jan. 24, 2013

PALO ALTO, Calif., Jan. 24, 2013 /PRNewswire/ --Varian Medical Systems (NYSE:
VAR) has received an FDA 510(k) clearance for the latest version of its
Vitesse™ real time planning for HDR brachytherapy which is used to plan and
perform high-dose-rate (HDR), ultrasound-guided brachytherapy treatments for
prostate cancer.

"This version of Vitesse reduces the number and complexity of steps involved
in planning and completing a treatment.It eliminates the need for a data
transfer to another software program, and avoids moving the patient to a CT
scanner for images in the middle of the procedure. For these reasons, most
clinicians will see a reduction in the amount of time needed to complete these
treatments, often by as much as an hour and a half," said Tim Clark, marketing
manager for Varian BrachyTherapy.

HDR brachytherapy involves delivering radiotherapy from inside the body by
temporarily placing a tiny radioactive source directly into the tumor or other
targeted area. Using a robotic device called an afterloader, clinicians place
the radioactive source into positions through needles that have been inserted
into the area being treated. The source is then moved within the needles under
computer control to create the specified dose distribution within the
patient's anatomy.

Using the latest version of Vitesse, HDR brachytherapy treatment plans can be
created in a real-time environment, using ultrasound images generated in the
operating room rather than CT scans generated elsewhere.This avoids the need
to move the patient to a CT scanner room for imaging after the needles have
been put in place.The process can now be completed entirely within the
Vitesse program, from capturing the ultrasound image to finalizing an approved
treatment plan.

In addition to receiving FDA 510(k) clearance which permits sale of the
Vitesse software in the United States, Varian has also obtained the CE Mark
which permits sales in the European Union and other countries where the CE
Mark is recognized.

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, United States
Meryl Ginsberg, 650.424.6444

SOURCE Varian Medical Systems

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