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trilogy with external system gating interface
Varian Medical Systems
Summary: The Trilogy with External System Gating Interface by Varian Medical Systems is a medical device used in radiotherapy to enhance treatment precision by synchronizing radiation delivery with patient breathing. It is primarily used by radiation oncologists in cancer treatment centers.
FDA Clearance Information
Pathway
510K
Number
K081188 ↗
Decision Date
July 14, 2008
Product Code
IYE
Device Class
Class 2
Evidence
0 studies
The Trilogy with External System Gating Interface was cleared by the FDA via the 510(k) pathway on July 14, 2008. It is manufactured by Varian Medical Systems and classified as a Class 2 device under product code IYE.
What It Is
The Trilogy with External System Gating Interface is a sophisticated radiotherapy device designed to improve the accuracy of radiation delivery by accounting for patient movement, particularly breathing. It employs external sensors to monitor the patient's respiratory cycle, allowing the linear accelerator to deliver radiation precisely when the target tumor is in the optimal position. This reduces the risk of damaging surrounding healthy tissues and enhances treatment efficacy.
Clinical Applications
This device is commonly used in the treatment of tumors located in areas affected by respiratory motion, such as the lungs and upper abdomen. Radiation oncologists utilize it in settings like cancer treatment centers and hospitals to treat patients with lung cancer, liver tumors, and other thoracic or abdominal malignancies. It is particularly beneficial for patients who require high precision in radiation delivery to minimize exposure to healthy tissues.
Indications for Use
The device is indicated for use in patients undergoing radiotherapy where tumor motion due to breathing can affect treatment accuracy. It is suitable for conditions like lung cancer and other tumors in the thoracic or abdominal regions where respiratory gating can enhance treatment precision.
Practical Considerations
The device requires careful setup and calibration to ensure accurate synchronization with the patient's breathing cycle. Compatibility with existing linear accelerators should be verified, and clinicians should be trained in its operation to maximize its benefits. Regular maintenance and checks are essential to ensure optimal performance.
Related Literature
The linked study evaluated the effectiveness of linear accelerator gating using real-time electromagnetic tracking. It found that using implanted wireless transponders for real-time feedback on tumor location significantly improved the accuracy of radiation delivery without additional imaging doses to the patient. However, the study noted limitations in correlating external anatomy with internal tumor position, highlighting the importance of precise sensor placement and patient-specific calibration.
Frequently Asked Questions
What is Trilogy with External System Gating Interface used for?
It is used to enhance the precision of radiotherapy by synchronizing radiation delivery with the patient's breathing cycle, particularly for tumors affected by respiratory motion.
What specialties typically use this device?
Radiation oncologists primarily use this device in cancer treatment centers and hospitals for treating thoracic and abdominal tumors.
What are the FDA-cleared indications?
It is cleared for use in radiotherapy to improve treatment accuracy for tumors affected by breathing motion, such as those in the lungs and upper abdomen.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.