Varian’s Updated Radiation Software Gets FDA OK

Oncology and X-ray products company Varian Medical Systems has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its updated Vitesse software. The tool is intended for providing high-dose-rate (HDR) brachytherapy therapy for prostrate cancer treatment, using real-time ultrasound guidance.

“This version of Vitesse reduces the number and complexity of steps involved in planning and completing a treatment,” said Tim Clark, marketing manager for Varian Brachytherapy. “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.”

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.

According to Varian, Vitesse allows HDR brachytherapy treatment plans to be created in real-time using ultrasound images generated in the operating room rather than CT (computed tomography) 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. Vitesse’s claim to fame is that the entire treatment process can be completed within the software program, from capturing the ultrasound image to finalizing an approved treatment plan.

Vitesse software is also CE marked for sale in the European Union and other countries that accept the regulation.

Varian is based in Palo Alto, Calif.