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Eclipse Treatment Planning System
Summary: The Eclipse Treatment Planning System by Varian Medical Systems is a device used for planning radiotherapy treatments. It is primarily used in calculating dosimetric parameters for cancer treatment. Key evidence highlights its efficiency in dose calculation and comparison with other systems.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K172163 ↗
Decision Date ?
August 15, 2017
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The Eclipse Treatment Planning System was cleared by the FDA via the 510(k) pathway on August 15, 2017. It is manufactured by Varian Medical Systems and classified as a Class 2 device.
What It Is
The Eclipse Treatment Planning System is a software tool designed for planning radiation therapy treatments. It calculates the optimal dose distribution for targeting tumors while minimizing exposure to surrounding healthy tissues. It is intended for use in clinical settings to assist in the treatment of cancer patients.
FDA-Cleared Indications
- Radiation therapy treatment planning
- Calculation and evaluation of radiation dose distributions
- Use in clinical radiotherapy planning for cancer treatment
Clinical Applications
- Planning external-beam radiation therapy treatments
- Calculating radiation dose distributions for treatment plans
- Evaluating dose to the target and surrounding organs at risk
- Planning complex radiation treatments, including intensity-modulated radiation therapy and volumetric modulated arc therapy, when supported by the cleared system configuration
Evidence Summary
The available literature includes 15 studies, comprising various study types such as RCTs and retrospective analyses, conducted between 2022 and 2024. These studies focus on the system's dosimetric accuracy and efficiency in clinical settings.
Reported Outcomes
Published studies report that the Eclipse system provides accurate dose calculations, comparable to other systems like the PRIMO Monte Carlo code. It is effective in ensuring precise dose delivery to target volumes while sparing organs at risk. The system's ability to handle complex treatment plans, such as those involving dual-layer multi-leaf collimators, is also highlighted.
Safety Profile
Reported complications include potential discrepancies in dose calculations due to variations in measurement parameters and model configurations. However, no significant adverse events have been directly attributed to the system's use in the reviewed studies.
Evidence Limitations
The evidence is limited by the variability in study designs and the specific focus on certain cancer types. Further research is needed to explore the system's performance across a broader range of clinical scenarios and to validate findings in larger patient populations.
Practical Considerations
- This is software rather than an implanted or disposable device, so it does not have a physical size, catheter diameter, or vessel-compatibility requirement.
- Treatment plans require patient imaging, accurate anatomy definition, treatment-machine data, and review by qualified radiation oncology professionals.
- The system must be configured and validated for the radiation-delivery equipment, treatment technique, dose-calculation algorithm, and clinical workflow in use.
- MRI images may be used for treatment planning only when they are acquired, registered, and quality-checked according to the institution's approved workflow; the software itself is not an MRI-safe implant or device.
- Independent plan checks, quality assurance, and clinician approval are required before radiation is delivered.
Frequently Asked Questions
What are the clinical indications for Eclipse Treatment Planning System?
The Eclipse system is indicated for use in planning radiotherapy treatments, particularly in cancer cases requiring precise dose calculations.
What outcomes have been reported in clinical studies?
Studies report accurate dose calculations and effective dose delivery to target volumes, with comparisons showing performance on par with other systems.
What complications have been reported?
Safety data indicate potential calculation discrepancies due to measurement parameter variations, but no significant adverse events have been reported.
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.