Varian Medical Systems receives 510(k) clearance for two new products
The FDA has granted 510(k) clearance to Varian Medical Systems Inc. for its 3D cone-beam computed tomography imaging system on a radiation therapy simulation and verification device and the company's Trilogy linear accelerator for stereotactic and advanced forms of radiotherapy.

The cone-beam CT option on Varian's Acuity simulator for dynamic targeting image-guided radiation therapy (IGRT) provides 3D digital images to verify and enhance radiation therapy treatment plans.

Cone-beam CT is designed to generate 3D images of tumors and surrounding anatomy. Varian has integrated the Acuity imaging system with its software for image management and treatment planning, so doctors can review, verify and finalize treatment plans and patient positions prior to commencing treatments.

The Acuity system's 3D cone-beam imaging also will be used for brachytherapy treatment planning and to guide the placement of catheters and seeds.

Varian plans to begin shipments of cone-beam CT on the Acuity in the second half of its current fiscal year, which ends Sept. 30.

The Trilogy system is designed 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 currently is taking orders for the Trilogy system. Plans are to begin shipments in the second half of Varian's FY04.

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.