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Eclipse Treatment Planning System
Summary: The Eclipse Treatment Planning System by Varian is a device used for planning radiation therapy treatments. It is primarily used in radiotherapy for cancer patients, with evidence supporting its efficacy in dose calculation and treatment planning.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K102011 ↗
Decision Date ?
September 3, 2010
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The Eclipse Treatment Planning System received FDA clearance through the 510(k) pathway on September 3, 2010. 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 platform designed to assist clinicians in planning radiation therapy treatments. It calculates the optimal dose distribution for targeting tumors while minimizing exposure to surrounding healthy tissues.
FDA-Cleared Indications
- Used by qualified professionals to create radiation therapy treatment plans.
- Used to calculate and evaluate radiation dose distributions for external-beam radiotherapy.
- Used in the planning of radiation treatments for patients with cancer.
Clinical Applications
- Planning external-beam radiation therapy for solid tumors.
- Calculating radiation dose distributions and treatment-field arrangements.
- Evaluating dose to the tumor and nearby organs at risk.
- Supporting plan review and optimization before radiation treatment is delivered.
Evidence Summary
The available literature includes 15 studies, comprising various study types such as RCTs, prospective, and retrospective analyses. These studies span from 2022 to 2024, providing insights into the system's performance and clinical utility.
Reported Outcomes
Published studies report that the Eclipse Treatment Planning System effectively calculates dose distributions for radiotherapy, with particular efficacy in photon and electron dose calculations. It has been compared favorably to other systems like the PRIMO Monte Carlo code in terms of dosimetric accuracy.
Safety Profile
Reported complications include potential inaccuracies in dose calculations due to model uncertainties, such as those related to the multi-leaf collimator model. However, no significant adverse events have been documented in the reviewed studies.
Evidence Limitations
The evidence base is limited by the variability in study designs and the focus on specific technical aspects of the system. Further research is needed to explore long-term clinical outcomes and broader safety profiles.
Practical Considerations
- This is software, not an implantable or patient-contact device; it does not have a physical size or vessel compatibility requirement.
- Treatment plans depend on accurate patient imaging, anatomy, contouring, prescribed dose, machine data and quality assurance.
- Compatibility must be verified with the radiation therapy equipment, imaging systems and oncology information systems used by the treatment facility.
- MRI images may be used for planning when appropriately registered and validated, but MRI compatibility applies to the imaging workflow and any associated hardware, not to the software itself.
- The system should be used by trained radiation oncology professionals under institutional quality-control procedures.
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 for cancer patients, particularly in scenarios requiring precise dose calculations.
What outcomes have been reported in clinical studies?
Studies have reported effective dose calculation and treatment planning capabilities, with favorable comparisons to other systems in terms of dosimetric accuracy.
What complications have been reported?
Safety data indicate potential inaccuracies in dose calculations due to model uncertainties, 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.