CALYPSO SOFT TISSUE (17G) BEACON TRANSPONDER

Calypso System

Organ motion is variable and unpredictable, posing challenges during delivery of external beam radiation therapy to cancer treatments. The ability to track target motion in real time during treatment and gate the delivery beam can enable reduction in the margins between the clinical target volume (CTV) and the planning target volume (PTV). The Calypso® system provides these capabilities. The Calypso system is a localization system designed for use during radiation therapy that provides accurate, objective and continuous

non-ionizing target localization information for initial patient alignment, target position monitoring during radiation treatment delivery and low-

latency gating of the treatment beam. Use of Calypso for target localization is based on the system’s detection of an electromagnetic signal generated by Beacon® transponders implanted in or near the treatment target.

RAD 10391 2/2016

Specifications are subject to change without notice. Not all features or products are available in all markets.

Intended Use SummaryThe Calypso System, including its associated Soft Tissue Beacon transponder, 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. Soft Tissue Beacon Transponders used as part of the Calypso System for monitoring patient motion are indicated for use for permanent implantation in the prostate gland and prostatic bed and in soft tissue.

Important Safety InformationImplanted 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 Soft Tissue 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 Soft Tissue Beacon Transponders is not appropriate for all patients. Patients should discuss the potential for side effects and their severity, as well as the benefits of the Calypso System and its associated Beacon transponders with their doctors to make sure it is right for them.

Medical Advice DisclaimerVarian as a medical device manufacturer cannot and does not recommend specific treatment approaches. Individual treatment results may vary.

©2005-2016 Varian Medical Systems, Inc. All rights reserved. Varian, Varian Medical Systems, and ARIA are registered trademarks, and Acuity and Eclipse are trademarks of Varian Medical Systems, Inc. All other trademarks are the property of their respective owners.

USA, Corporate Headquarters and Manufacturer

Varian Medical SystemsPalo Alto, CATel. 650 . 493.4000varian.com

EMEA, CIS and India Headquarters

Varian Medical SystemsInternational AGCham, SwitzerlandTel. 41 . 41.749.88.44

Latin American Headquarters

Varian Medical SystemsBrasil Ltda.São Paulo, BrazilTel. 55 . 11 .3457.2655

Asia Pacific Headquarters

Varian Medical SystemsPacific, Inc.Kowloon, Hong KongTel. 852.2724.2836

Australian Headquarters

Varian Medical SystemsAustralasia Pty Ltd.Sydney, AustraliaTel. 61 .2 . 9485.0111

Tumors in the abdominal region can be difficult to visualize with kV imaging due to the significant amount of motion during treatment delivery and similar densities of tumor and surrounding tissues. In addition, interventional radiologists performing percutaneous implants in these regions prefer smaller needle gauges than the 14G version

of the Calypso transponder. To address these challenges Varian is introducing a new smaller 17G beacon that can be used for tracking motion of soft tissue tumors during treatment delivery. This new Soft Tissue Beacon transponder has been cleared by the U.S. Food and Drug Administration and is CE marked for implantation into soft tissue throughout the body, with the exception of the lung. This new Soft Tissue Beacon has a 50% smaller cross-section area than the current 14G version. Clinicians can use the new transponder in most places where they would have used standard fiducial markers such as gold seeds to localize a tumor with the added benefit of continuous position tracking throughout the treatment delivery and low-latency (<100 ms) beam gating.

The Calypso system can help clinicians with accurate and efficient patient set up, real-time targeting and motion management during radiation therapy treatments for soft tissue targets such as tumors in the liver, prostate and pancreas. Use of the 17G transponder can provide confidence that the prescribed dose is delivered to the PTV. This also enables a reduction in treatment margins resulting in an increased sparing of normal healthy tissue.

Three Beacon transponders and three introducer needles are provided in each Beacon Care Package.