📊 Evidence-Based Reference
Eclipse Treatment Planning System
Summary: The Eclipse Treatment Planning System by Varian Medical Systems is a device used for planning radiation therapy treatments. It is primarily used in radiotherapy to calculate and optimize dose distributions. Key evidence highlights its accuracy in dose calculations and challenges with metal artefacts.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K170969 ↗
Decision Date ?
July 5, 2017
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The Eclipse Treatment Planning System was cleared by the FDA through the 510(k) pathway on July 5, 2017. It is manufactured by Varian Medical Systems and classified as a Class 2 device under product code MUJ.
What It Is
The Eclipse Treatment Planning System is a software platform designed for planning radiation therapy treatments. It calculates and optimizes dose distributions for photon and electron beams, aiding clinicians in delivering precise radiation doses to target tissues while sparing healthy organs.
FDA-Cleared Indications
- Used to create treatment plans for radiation therapy.
- Calculates and evaluates dose distributions for photon and electron radiation beams.
- Supports treatment planning intended to deliver radiation to target tissues while limiting dose to surrounding normal tissues.
Clinical Applications
- Planning external-beam photon radiation therapy.
- Planning electron beam radiation therapy.
- Calculating radiation dose distributions in target tissues and organs at risk.
- Optimizing treatment plans for complex radiation therapy treatments.
- Planning treatments involving heterogeneous tissues or regions affected by metal-related imaging artifacts, when supported by the applicable system configuration and validation.
Evidence Summary
The literature includes 15 studies, encompassing various study types such as RCTs and retrospective analyses, published between 2022 and 2024. These studies evaluate the system's dosimetric accuracy and its performance in different clinical scenarios.
Reported Outcomes
Published studies report that the Eclipse system provides accurate dose calculations for both photon and electron beams. It is effective in managing dosimetric uncertainties and has been compared favorably with Monte Carlo simulations. However, challenges remain in accurately calculating doses near metallic elements.
Safety Profile
Reported complications include dose calculation errors in the presence of metal artefacts, which can lead to inaccuracies in treatment planning. These artefacts degrade image quality, affecting the delineation of key structures.
Evidence Limitations
Evidence gaps include the need for more studies on the system's performance in diverse clinical settings and with different tissue heterogeneities. Further research is needed to improve dose calculation accuracy near metallic implants.
Practical Considerations
- This is software, not an implanted or patient-contact device; it does not have physical size options.
- The system must be used with compatible treatment-planning, imaging, treatment-delivery and quality-assurance workflows.
- Dose calculations require appropriate patient imaging, tissue-density information, beam data and clinical validation.
- Metal implants and imaging artifacts can affect contouring and dose calculation; additional review and quality assurance may be required.
- It is not an MRI-safe device in the usual implantable-device sense. MRI images may be imported for planning when the scanner, imaging workflow and software configuration are compatible and validated.
Frequently Asked Questions
What are the clinical indications for Eclipse Treatment Planning System?
The Eclipse system is indicated for use in planning radiation therapy treatments, particularly for calculating and optimizing dose distributions in cancer patients.
What outcomes have been reported in clinical studies?
Studies report accurate dose calculations and effective management of dosimetric uncertainties, with favorable comparisons to Monte Carlo simulations.
What complications have been reported?
Safety data indicates complications with dose calculation errors near metal artefacts, affecting treatment accuracy.
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.