Varian Medical Systems Receives FDA 510k Clearance for Trilogy™ System | Varian

Varian Medical Systems Receives FDA 510k Clearance for Trilogy™ System

PALO ALTO, CA--January 9, 2004--Varian Medical Systems, Inc. (NYSE:VAR) has received FDA 510(k) clearance for its Trilogy system, the world's first and most comprehensive linear accelerator for stereotactic as well as advanced forms of radiotherapy. The Trilogy™ system can be used to deliver stereotactic radiosurgery, fractionated stereotactic radiation therapy, and intensity-modulated radiosurgery, as well as 3D conformal radiotherapy, SmartBeam IMRT, and Dynamic Targeting IGRT. Varian is now taking orders for the Trilogy system, and plans to commence shipments in the second half of FY 2004.

"Trilogy is the first practical, clinically-viable system for delivering all forms of external-beam radiation therapy," said Timothy E. Guertin, president of Varian's Oncology Systems business. "It will enable doctors to choose and use the most appropriate treatment modality for treating cancer in the body or the head and neck, and to deliver the full spectrum of treatments, all on one machine in a single room."

With Trilogy, doctors have the option to treat small lesions using stereotactic radiosurgery, which is delivered in a single treatment, or stereotactic radiotherapy, which is delivered over a period of a few days. The Trilogy system can also be used for traditional radiation therapy, which is delivered in daily small doses over a period of weeks.

At the core of the Trilogy system is Varian's 23EX Clinac® linear accelerator, which has been enhanced for stereotactic applications that involve delivering higher doses of radiation to smaller areas with more precision over a shorter period of time. The maximum dose delivery rate has been increased from 600 to 1000 monitor units (MU) per minute, and the machine's isocenter, or focal point, has been reduced to encompass a one millimeter diameter sphere. The treatment couch has been made movable by remote control, which speeds up treatment and maximizes the number of beam angles that can be used to optimize treatment.

The Trilogy system incorporates Varian's Dynamic Targeting™ Image-Guided Radiation Therapy (IGRT) accessories for improved treatment precision. These currently include Varian's new PortalVision™ aS1000, an electronic portal imaging device that produces high-resolution images for patient positioning, treatment verification, and quality assurance. Trilogy was also designed to eventually accommodate an on-board imaging device and software that can give doctors radiographic (two-dimensional), fluoroscopic (time-lapse), and cone-beam CT (three dimensional) images for even more precise patient positioning and tumor localization.