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Varian Receives FDA 510(k) Clearance for Calypso®

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Varian Receives FDA 510(k) Clearance for Calypso®

Soft Tissue Beacon® Transponder - Jul 21, 2014

New clearance expands the indications for which clinicians will be able to use Varian's Calypso real-time tracking device for monitoring motion during radiotherapy treatments for cancer
Jul 21, 2014

PALO ALTO, Calif., July 21, 2014 /PRNewswire/ -- Varian Medical Systems (NYSE: VAR) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a Calypso® soft tissue Beacon® transponder that can help enhance the precision of radiotherapy and radiosurgery treatments for cancer.

The size of a grain of rice, the new transponders can be implanted within soft tissue throughout the body, with the exception of the lung. The Calypso GPS for the Body® system can then continuously track and monitor the position of the transponders, so that the high energy treatment beams can be precisely aimed to minimize exposure of surrounding healthy tissues. An earlier version of the Calypso Beacon transponder was cleared for use specifically in the prostate and prostatic bed; the new clearance makes the system applicable for many other types of cancer.

Calypso Beacon transponders emit a non-ionizing electromagnetic signal that is tracked in real time by the Calypso system, in order to guide treatment beams to precisely target tumors during radiotherapy and radiosurgery with medical linear accelerators, such as Varian's Edge™ radiosurgery system.

"With the new transponder, clinicians can use the Calypso system most places they would have used standard fiducial markers, such as gold seeds, to localize a targeted tumor, but with the added benefit of continuous tumor position tracking throughout treatment delivery," said Andrea Morgan, Calypso product manager. "Other types of fiducial markers have to be localized using X-rays, which add more ionizing radiation to the process. We're pleased to be able to make the system available to clinicians who want to use it more broadly, not just for conventional radiotherapy but for some of the newer approaches, like stereotactic body radiotherapy (SBRT), which involves delivering higher radiation doses very quickly. For treatments like that, accurate targeting is essential, and the new Calypso transponders have an important role to play."

"I have been using standard fiducial markers, particularly when treating tumors of the pancreas and liver," said Mary Feng, MD, associate professor in the Department of Radiation Oncology at the University of Michigan. "It is essential that we know exactly where the tumor is at all times, and that we have a way of responding if the tumor moves during treatment. I'm excited about the prospect of using the Calypso tracking system treating in areas where it is very hard to see the tumor because of the lack of contrast with surrounding soft tissues."

The new Calypso soft tissue Beacon transponders can only be used with the latest upgrade of the Varian Calypso system (version 3.0). Current Calypso Beacon transponders for the prostate are not appropriate for the new soft tissue indication due to device and labeling differences. "Initial use of the new device is expected towards the end of the year," said Corey Zankowski, vice president of product management at Varian. "We anticipate full commercial roll-out of the product sometime next year."

Calypso soft tissue Beacon transponders are cleared for the U.S. market only.

Calypso System Intended Use Summary

The Calypso System, including its associated Beacon transponders, is intended to align and/or monitor the patient's position in relation to the radiation beam used for treatment. The Calypso System may also be used to regulate the treatment beam on Varian and Siemens radiation delivery systems by turning the beam on and off ("gating" it) due to movement during treatment. Beacon transponders used as part of the Calypso System for monitoring patient motion are indicated for use on the skin surface for temporary external placement and for permanent implantation, specifically in the prostate and prostatic bed as well as in soft tissue. Beacon transponders are not intended for use in the lung.

Calypso Safety Information

Implanted Beacon transponders may migrate such that they pass from the patient's body or move to a different location within the body. The most frequent side effects associated with implantation of Beacon transponders are typically temporary and may include, but are not limited to, pain, bleeding, and infection. In some patients, these side effects may be serious. Use of the Calypso System and its associated Beacon transponders is not appropriate for all 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, 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, digital detectors, and image processing workstations for X-ray imaging in medical, scientific, and industrial applications and also supplies high-energy X-ray devices for cargo screening and non-destructive testing applications. Varian Medical Systems employs approximately 6500 people who are located at manufacturing sites in North America, Europe, and China and approximately 70 sales and support offices around the world. For more information, visit http://www.varian.com or follow us on Twitter.

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 be able to," "can help," "can be," "can use," and "is expected," and "we anticipate," 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:

Varian Medical Systems, United States
Meryl Ginsberg, 650.424.6444
meryl.ginsberg@varian.com

SOURCE Varian Medical Systems

http://bit.ly/1dJpfRQ

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