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

Wednesday, January 2, 2008 General News
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PALO ALTO, Calif., Jan. 2 Varian Medical Systems(NYSE: VAR) has received FDA 510(k) clearances for its RapidArc(TM)radiotherapy technology, a revolutionary advance that makes it possible todeliver image-guided, intensity-modulated radiation therapy (IMRT) two toeight times faster and more precisely than is possible with conventional IMRTor helical tomotherapy.
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"RapidArc represents a major medical advance that will change the wayradiation therapy is planned and delivered," says Dow Wilson, president ofVarian's Oncology Systems business. "Our primary goal with this product is toimprove clinical outcomes. In addition, we discovered that we couldsimultaneously improve treatment efficiency significantly. RapidArc shouldmake better-quality radiotherapy a more affordable, more accessible treatmentoption, and enable more cancer patients to receive a higher standard of care."
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RapidArc, Varian's new technology for delivering volumetric modulated arctherapy, quickly delivers a complete IMRT treatment in a single rotation ofthe treatment machine around the patient. The two FDA clearances for RapidArccover the treatment hardware and the RapidArc treatment planning softwaremodule in Varian's Eclipse(TM) treatment planning system. Varian will begintaking orders for RapidArc immediately, and will begin delivering it tocustomers in the spring of 2008.

"Customer interest in RapidArc is tremendous," said Wilson. "Thistechnology extends the versatility of Varian's image-guided radiotherapysystem, adding volumetric arc therapy to other advanced capabilities includingfixed-beam IMRT and stereotactic treatments. Doctors can use RapidArc forbetter prostate and head and neck treatments, and still offer fixed beam IMRTtreatments with motion management for lung and breast tumors and electrontreatments for patients with lymphomas and skin cancers. No other treatmenttechnology offers this kind of versatility for customizing treatmentsaccording to each patient's specific needs."

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

RapidArc Technology

RapidArc technology utilizes a sophisticated, proprietary algorithm thatcreates a finely-shaped IMRT dose distribution that closely matches the sizeand 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 duringthe treatment based on the patient's unique anatomy, and 3) the rate at whichthe dose is delivered. These technologies work together to make RA the mostrevolutionary advance in radiation therapy in terms of speed, efficiency, andconformality.

"The RapidArc planning algorithm exploits the unique characteristics ofVarian's most advanced medical linear accelerators, which can deliver dose atdifferent rates, and the multileaf collimator, which is used to shape the beamso it conforms to the shape of the tumor," said Corey Zankowski, seniordirector of software systems marketing at Varian. "Not only is the treatmentfaster to deliver, it is also easier to plan and execute. That means a higherquality 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'sleadin
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