Varian Medical Systems Receives FDA 510k Clearance for Trilogy System.Business Editors/Health/Medical Writers PALO ALTO, Calif.--(BUSINESS WIRE)--Jan. 9, 2004 Versatile Linear Accelerator Will Deliver Stereotactic stereotactic /ster·eo·tac·tic/ (-tak´tik) 1. characterized by precise positioning in space; said especially of discrete areas of the brain that control specific functions. 2. pertaining to stereotactic surgery. Treatments As Well As SmartBeam(TM) IMRT IMRT Intensity-modulated radiation therapy Radiation oncology A format for delivering high-dose RT to regions–eg, nasopharynx, that are surrounded by radiation-sensitive areas; in IMRT, a broad radiation field is divided into hundreds of small pencil beams, And Dynamic Targeting(TM) IGRT IGRT Image Guided Radiation Therapy (Image-Guided Radiation Therapy Image-guided radiation therapy (IGRT) is the process of frequent two and three-dimensional imaging, during a course of radiation treatment, used to direct radiation therapy utilizing the imaging coordinates of the actual radiation treatment plan. ) Varian Medical Systems Varian Medical Systems (NYSE: VAR) is engaged in the design and manufacture of advanced equipment and software solutions for treating cancer with radiation, as well as x-ray tubes for original equipment manufacturers, replacement x-ray tubes and flat-panel digital subsystems , Inc. (NYSE NYSE See: New York Stock Exchange :VAR) has received FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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(TM) 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 external-beam radiation therapy External radiation Radiation therapy The aiming of high-energy radiation at the center of a CA, which may also be used to manage choroidal neovascularization in age-related macular degeneration. See Radiation oncology. ," 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(R) 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(TM) Image-Guided Radiation Therapy (IGRT) accessories for improved treatment precision. These currently include Varian's new PortalVision(TM) 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 radiographic (rā´dēōgraf´ik), adj relating to the process of radiography, the finished product, or its use. (two-dimensional), fluoroscopic Fluoroscopic (fluoroscopy) An x-ray procedure that produces immediate images and motion on a screen. The images look like those seen at airport baggage security stations. Mentioned in: Hypotonic Duodenography (time-lapse), and cone-beam CT (three-dimensional) images for even more precise patient positioning and tumor localization Customizing software and documentation for a particular country. It includes the translation of menus and messages into the native spoken language as well as changes in the user interface to accommodate different alphabets and culture. See internationalization and l10n. . About Varian Medical Systems Varian Medical Systems, Inc., (NYSE:VAR) of Palo Alto, Calif., is the world's leading manufacturer of integrated cancer therapy systems and is a premier supplier of X-ray tubes and flat-panel sensors for imaging in medical, scientific, and industrial applications. Varian Medical Systems employs approximately 2,900 people at manufacturing sites in North America and Europe and in some 48 sales and support offices worldwide. The company reported sales of $1 billion in its most recent fiscal year ended September 26, 2003. For more information, visit www.varian.com. Forward Looking Statements This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995, which provides a "safe harbor" for these types of statements. These forward-looking statements are subject to risks and uncertainties that could cause the actual results of Varian Medical Systems, Inc. to differ materially from management's current expectations. These risks and uncertainties include, without limitation, product demand and market acceptance risks; the availability of healthcare reimbursement; the impact of managed care initiatives in the U.S. on capital expenditures; and other risks detailed in Varian Medical Systems, Inc. filings with the Securities and Exchange Commission. Varian Medical Systems, Inc. assumes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. |
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