Varian Medical Systems' New, Enhanced Variseed 7.0 Treatment Planning Tool for Permanent Seed Implant Brachytherapy Gains FDA 510k Clearance.

Business Editors/Health & Medical Writers

SALT LAKE CITY--(BW HealthWire)--July 23, 2001

VariSeed 7.0 Optimized to Address Real Time

Planning and Image Guided Therapy

AAPM Booth No. 1017. Varian Medical Systems, Inc. (NYSE:VAR) announces the release of a new version of its VariSeed(TM) treatment planning software for permanent seed implant brachytherapy used in treating prostate cancer. VariSeed 7.0, which received 510(k) clearance from the U.S. Food and Drug Administration (FDA) earlier this month, is enriched with new features designed to overcome technical difficulties associated with the protocol, to allow real time planning in the procedure room, and to enable functional image guided therapy. The software is being introduced at the annual American Association of Physicists in Medicine (AAPM) meetings in Salt Lake City, July 22-26, 2001.

"According to the American Cancer Society, prostate cancer remains the second leading cause of cancer death in American men, with 180,000 new cases diagnosed each year," said William Hyatt, general manager of Varian Medical Systems' Brachytherapy business. "Over the past twelve years or so, there has been an annual doubling of the number of patients undergoing this procedure. Up to 60,000 American men may receive permanent prostate seed implants this year. VariSeed 7.0 is designed to improve the accuracy of the process."

Real Time (Intra-Operative) Brachytherapy Planning

VariSeed 7.0 offers the option of utilizing real-time planning, which enables radiation oncologists to create a volume study, a proposed plan, and a completed post plan all as part of the implant process itself. Prior to the development of this functionality, each of these steps had to be executed separately, making accuracy difficult and requiring patients to make multiple visits to the clinic or hospital. "Real-time planning gives the clinician the complete dosimetry picture right there in the procedure room, while there is still time to do something with it," said Hyatt.

With VariSeed's new real-time planning capabilities, clinicians can overlay their preoperative plans onto a live ultrasound image and adjust needles or seeds according to differences between the pre-operative plan and the actual implant. The dose distribution can also be displayed as it is evolving on the live ultrasound view. The addition of dosimetric alerts enable clinicians to see where an implant may be deviating from the plan, and make adjustments before the procedure is completed. This new system should help clinicians to improve the quality of prostate seed implants, which should in turn lead to better outcomes for patients undergoing this procedure.

Image Registration and Fusion

VariSeed 7.0 also incorporates powerful new image registration and fusion tools. Clinicians can use it to register ultrasound images used to guide the needles and deliver the radioactive seeds to diagnostic images, enabling them to focus the treatment on the disease "hot spots" (areas of high tumor metabolism). Prostate margins seem to be visualized best using ultrasound or Magnetic Resonance Imaging (MRI), while seeds show up best in Computed Tomography (CT) images. VariSeed allows clinicians to transfer the prostate contours from ultrasound or MRI to CT scans taken after the seeds are implanted, yielding a better calculation of the actual dose delivered to the prostate.

Functional Image Guided Therapy

New studies have shown that functional images created using Single Photon Emission Computer Tomography (SPECT) and MRI can help clinicians distinguish cancerous regions from normal tissue. These images reveal the location of disease by showing concentrations of chemicals that are more prevalent in cancerous tissue. By fusing functional images with those from an ultrasound study, clinicians can create treatment plans that target the actual disease, rather than the entire prostate. "This kind of work is very new and not yet widely available," said Hyatt, "but VariSeed 7.0 supports it. We think that there will be more precisely targeted treatment in the future."

Other Unique Features

VariSeed 7.0 offers a number of unique features. These include the SeedFinder(TM) function, which automatically locates seeds in a CT data series, dramatically reducing the time taken to create post-plans. Other unique features are rules-based dose optimization for creating ideal plans, dynamic interpolation of contour entries for faster planning, and auto trace solid line contours from ultrasound images.

For more information about VariSeed 7.0 treatment planning software, call 888/666-7847 ext. 240 or visit the web site at www.varian.com.

Varian Medical Systems, Inc. (NYSE:VAR) of Palo Alto, Calif., is the world's leading manufacturer of integrated cancer therapy systems as well as X-ray tubes and flat-panel sensors for imaging in medical, scientific, and industrial applications. Varian Medical Systems employs approximately 2,400 people and reported sales of $690 million in its most recent fiscal year ended September 29, 2000.