Varian Medical Systems Receives FDA 510(k) Clearance for Vitesse(TM) Brachytherapy Treatment Planning Software
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(TM) 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 http://www.varian.com or follow us on Twitter.
FOR INFORMATION CONTACT:
Varian Medical Systems, United States
Meryl Ginsberg, 650.424.6444
SOURCE Varian Medical Systems