PALO ALTO, CA--November 3, 2004-- Varian Medical Systems, Inc. (NYSE: VAR) today announced it has received FDA 510(k) clearance for cone-beam CT imaging using the company's On-Board Imager ™ device for real-time image-guided radiation therapy (IGRT) with its Clinac and Trilogy™ linear accelerators. With this capability, Varian's On-Board Imager is the most comprehensive and versatile imaging system for fine-tuning patient positioning at the moment of treatment. The new cone-beam CT software was developed by scientists at Varian's Ginzton Technology Center (Mountain View, California) and Varian’s Imaging Laboratory (Baden, Switzerland), in close collaboration with customers.
This capability augments the image guidance toolkit already commercially available with the On-Board Imager device, encompassing radiographic (2-D imaging), fluoroscopic (motion pictures), and now, cone-beam CT (3-D imaging). Each of these imaging modes offers doctors different kinds of information about the tumor to be treated, and facilitates automated patient positioning just prior to treatment.
"The cone-beam CT imaging capability gives doctors an important third modality for pinpointing the exact location of the tumor," said Timothy Guertin, president of Varian’s Oncology Systems business. "It is especially useful when the tumor is far from any bony landmarks, and hard to distinguish from surrounding soft tissues. Having access to volumetric cone-beam CT data has the potential to significantly improve tumor targeting in these difficult cases."
"Varian's cone-beam CT technology has been proven on our Acuity™ treatment planning, simulation, and verification devices," Guertin added. "We have now successfully moved this capability to the linear accelerator."
Using Varian's cone-beam CT imaging technology, the On-Board Imager, an accessory to the medical linear accelerator, can be rotated once around the patient to quickly acquire a high-quality 3-D image of the tumor and surrounding anatomy. Just before treatment, clinicians can compare these 3-D images to reference images from the patient's treatment plan and make positioning adjustments that put the tumor directly in the path of the beam. Varian's On-Board Imager device, with its multiple imaging modalities, is a sophisticated tool for real-time image guidance that enables doctors to account for the constant changes in tumor position that occur due to normal physiological processes. The On-Board Imager can be used to facilitate the ultra-accurate delivery of conventional, conformal, and stereotactic forms of radiation therapy, for treatment of tumors in the head or body.
First cleared by the FDA in February of this year, by the end of September, 2004, Varian's On-Board imager had been installed at Emory University in Atlanta, Georgia; the Henry Ford Health System in Detroit, Michigan; the Hirslanden Klinik in Aarau, Switzerland; Karolinska University Hospital in Stockholm, Sweden; and at Memorial Sloan-Kettering Cancer Center in New York. It is slated for installation at another 79 cancer centers worldwide.
"The addition of the cone-beam CT capability is part of our ongoing commitment to making the On-Board Imager device the most versatile tool of its kind,"said Guertin. "Different forms of cancer require different treatment approaches. Our goal is to improve the precision and effectiveness of cancer treatment by giving doctors exactly what they need to deliver the best possible care for each and every patient."