Varian Medical Systems Receives FDA 510(K) Clearance For 3-D Cone-Beam Imaging System | Varian

Varian Medical Systems Receives FDA 510(K) Clearance For 3-D Cone-Beam Imaging System

PALO ALTO, CA — January 8, 2004 — Varian Medical Systems, Inc. (NYSE: VAR) has received FDA 510(k) clearance for the world's first commercially-available 3-D cone-beam computed tomography imaging system on a radiation therapy simulation and verification device. The cone-beam CT option on Varian's Acuity™ simulator for Dynamic Targeting™ image-guided radiation therapy (IGRT) provides 3-D digital images for verifying and enhancing radiation therapy treatment plans.

CONE-BEAM CT GENERATES 3-D IMAGES OF TUMORS AND SURROUNDING ANATOMY

Varian has integrated the Acuity imaging system with its software for image management and treatment planning, making it easy for doctors to review, verify, and finalize treatment plans and patient positions prior to commencing treatments. "3-D imaging will make it possible for clinicians to achieve better outcomes for their patients by sparing more healthy tissue while concentrating more cancer-killing radiation within targeted tumors," said Timothy E. Guertin, president of Varian's Oncology Systems business.  "Adding a cone-beam CT capability to our Acuity system is in keeping with our mission of putting powerful tools for image-guided radiation therapy into clinicians' hands, and of perpetually improving the effectiveness of radiation therapy technologies."

The Acuity system's 3-D cone-beam imaging also will be used for brachytherapy treatment planning and to guide the placement of catheters and seeds. The company is now taking orders for cone-beam CT on the Acuity device, and will commence shipments in the second half of FY2004.