Varian Medical Systems Receives FDA 510(k) Clearance for RapidArc(TM) Radiotherapy Technology

PALO ALTO, Calif., Jan. 2 /PRNewswire-FirstCall/ -- Varian Medical Systems has received FDA 510(k) clearances for its RapidArc(TM) radiotherapy technology, a revolutionary advance that makes it possible to deliver image-guided, intensity-modulated radiation therapy (IMRT) two to eight times faster and more precisely than is possible with conventional IMRT or helical tomotherapy.

"RapidArc represents a major medical advance that will change the way radiation therapy is planned and delivered," says Dow Wilson, president of Varian's Oncology Systems business. "Our primary goal with this product is to improve clinical outcomes. In addition, we discovered that we could simultaneously improve treatment efficiency significantly. RapidArc should make better-quality radiotherapy a more affordable, more accessible treatment option, and enable more cancer patients to receive a higher standard of care."

RapidArc, Varian's new technology for delivering volumetric modulated arc therapy, quickly delivers a complete IMRT treatment in a single rotation of the treatment machine around the patient. The two FDA clearances for RapidArc cover the treatment hardware and the RapidArc treatment planning software module in Varian's Eclipse(TM) treatment planning system. Varian will begin taking orders for RapidArc immediately, and will begin delivering it to customers in the spring of 2008.

"Customer interest in RapidArc is tremendous," said Wilson. "This technology extends the versatility of Varian's image-guided radiotherapy system, adding volumetric arc therapy to other advanced capabilities including fixed-beam IMRT and stereotactic treatments. Doctors can use RapidArc for better prostate and head and neck treatments, and still offer fixed beam IMRT treatments with motion management for lung and breast tumors and electron treatments for patients with lymphomas and skin cancers. No other treatment technology offers this kind of versatility for customizing treatments according to each patient's specific needs."

Plan studies comparing fixed-beam and helical IMRT with RapidArc show that RapidArc can reduce the amount of non-therapeutic radiation reaching healthy tissues during treatment. For example, in the case of head and neck cancer treatments, RapidArc plans are better at protecting critical structures like the spinal cord, brain stem, eyes, optic nerve and chiasm, parotid (salivary) glands, and brain. Moreover, with RapidArc's highly efficient use of the primary beam, secondary stray radiation caused by scatter and leakage are reduced by over 50 percent on average compared with fixed field IMRT.

RapidArc Technology

RapidArc technology utilizes a sophisticated, proprietary algorithm that creates a finely-shaped IMRT dose distribution that closely matches the size and shape of the tumor. It works by varying three parameters simultaneously: 1) the speed with which the treatment machine rotates around the patient, 2) the dimensions of the beam-shaping aperture, which change continually during the treatment based on the patient's unique anatomy, and 3) the rate at which the dose is delivered. These technologies work together to make RA the most revolutionary advance in radiation therapy in terms of speed, efficiency, and conformality.

"The RapidArc planning algorithm exploits the unique characteristics of Varian's most advanced medical linear accelerators, which can deliver dose at different rates, and the multileaf collimator, which is used to shape the beam so it conforms to the shape of the tumor," said Corey Zankowski, senior director of software systems marketing at Varian. "Not only is the treatment faster to deliver, it is also easier to plan and execute. That means a higher quality treatment that's easier on the clinicians and easier on the patients."

ABOUT VARIAN MEDICAL SYSTEMS

Varian Medical Systems, Inc., of Palo Alto, California, is the world's leading manufacturer of medical devices and software for treating cancer and other medical conditions with radiotherapy, radiosurgery, proton therapy, and brachytherapy. The company supplies informatics software for managing comprehensive cancer clinics, radiotherapy centers and medical oncology practices. Varian is a premier supplier of tubes and digital detectors for X-ray imaging in medical, scientific, and industrial applications and also supplies X-ray imaging products for cargo screening and industrial inspection. Varian Medical Systems employs approximately 4,400 people who are located at manufacturing sites in North America and Europe and in its 60 sales and support offices around the world. For more information, visit http://www.varian.com/.

FORWARD LOOKING STATEMENTS

Statements in this press release regarding future business, events, plans, objectives, expectations, estimates, and other similar matters, including, but not limited to, statements using the terms "will," "should," "can," and "will be" constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements contained in this press release are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated, including, but not limited to, the risks described in the company's Annual Report on Form 10-K and other reports filed from time to time by the Company with the Securities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this press release. The Company assumes no obligation to update or revise these forward-looking statements because of new information, future events, or otherwise.

FOR INFORMATION CONTACT: Spencer Sias, (650) 424-5782 spencer.sias@varian.com Meryl Ginsberg, (650) 424-6444 meryl.ginsberg@varian.com