PALO ALTO, CA — August 9, 2004 — Varian Medical Systems, Inc. (NYSE:VAR) today announced it has received FDA 510(k) clearance for a new suite of features that have been added to the company’s On-Board Imager™ system for Clinac® and Trilogy™ medical linear accelerators (linacs). With these new capabilities, Varian’s On-Board Imager becomes the first linac-based kV X-ray digital imaging system that can synchronize image acquisition with a patient’s respiratory cycle and automate “marker matching” for more precise tumor targeting. The new On-Board Imager features encompass:
Automated tumor marker detection. The On-Board imager is the first system of its kind to position a patient for treatment automatically and quickly by detecting and imaging gold seeds or other fiducial markers implanted in a tumor.
Monitoring and gating for tumor motion. No other treatment machine imaging system can characterize respiratory motion and automatically use the information to verify patient positioning and deliver treatments corrected for tumor motion.
Varian’s On-Board Imager was designed to improve the accuracy and effectiveness of cancer treatments. It is the first robotic, automated, clinically-practical system for image-guided radiation therapy (IGRT), enabling clinicians to obtain high-resolution digital images to pinpoint tumor sites, adjust patient positioning at the push of a button, and complete a treatment, all within the standard treatment time slot.
“By automating marker detection, we are giving clinicians a very powerful capability,” said Timothy Guertin, president of Varian’s Oncology Systems business.
“Tumors that develop within soft tissue, such as the prostate, can be hard to distinguish from the surrounding anatomy. One solution is for doctors to implant gold seeds or other markers into the tumor, adding another visual landmark. Now, the On-Board Imager can detect variations in marker position, and quickly reposition the patient so that the tumor is directly in line with the treatment beam. The new gating capabilities will facilitate more accurate treatment of cancer in the breast, lung, liver, and other upper abdominal sites affected by respiratory motion.”
First cleared by the FDA in February of this year, Varian’s On-Board Imager device has been installed at Karolinska University Hospital in Stockholm, Sweden; Emory University in Atlanta, Georgia; the Henry Ford Health System in Detroit, Michigan; and Memorial Sloan-Kettering Cancer Center in New York. An additional 46 units are slated for installation at cancer centers worldwide.
“Our plan all along has been to continue adding to the On-Board Imager’s capabilities,” said Richard Levy, Chairman and CEO of Varian Medical Systems. “There will be more new features in the future. It is deeply gratifying to see technological developments that have been years in the making coming to fruition for cancer patients.”