📊 Evidence-Based Reference
Leksell Gammaplan
Elekta Instrument Ab
Summary: Leksell GammaPlan is a treatment planning system for radiosurgery, primarily used in conjunction with the Leksell Gamma Knife. Key evidence highlights its efficacy in dose calculation and treatment planning.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K090972 ↗
Decision Date ?
July 20, 2009
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The Leksell GammaPlan was cleared by the FDA via the 510(k) pathway on July 20, 2009. It is manufactured by Elekta Instrument Ab and classified as a Class 2 device under product code MUJ.
What It Is
Leksell GammaPlan is a software system designed for planning radiosurgical treatments using the Leksell Gamma Knife. It facilitates precise dose calculations and treatment planning for various intracranial conditions.
FDA-Cleared Indications
- Software for planning and dose calculation for radiosurgical treatments performed with the Leksell Gamma Knife system.
Clinical Applications
- Planning stereotactic radiosurgery for intracranial targets
- Calculating and evaluating radiation dose distributions
- Creating treatment plans based on patient-specific brain imaging and anatomy
- Supporting treatment planning for use with the Leksell Gamma Knife system
Evidence Summary
The literature includes 12 studies, ranging from 2020 to 2023, encompassing various study types such as RCTs and retrospective analyses. These studies focus on the system's dosimetric accuracy and integration with imaging modalities.
Reported Outcomes
Published studies report that Leksell GammaPlan provides reliable dose calculations and supports effective treatment planning. It has been shown to enhance the precision of radiosurgical interventions, particularly when incorporating advanced imaging techniques.
Safety Profile
Reported complications include challenges in integrating certain imaging modalities with the current version of the software. However, no significant adverse events directly related to the use of Leksell GammaPlan have been documented.
Evidence Limitations
The evidence highlights the need for further research on the integration of newer imaging technologies with Leksell GammaPlan. Some studies also note limitations in the software's compatibility with advanced imaging techniques.
Practical Considerations
- It is a software planning system, not an implant or radiation source.
- Use requires compatibility with the applicable Leksell Gamma Knife system, imaging inputs and clinical workflow.
- Treatment planning depends on accurate patient imaging, target definition, dose prescription and verification by qualified specialists.
- The software itself is not an MRI device; MRI safety depends on the scanner, stereotactic frame or mask, markers and other equipment used during imaging and treatment.
- It does not replace clinical assessment, treatment verification or the judgment of the treating radiosurgery team.
Frequently Asked Questions
What are the clinical indications for Leksell GammaPlan?
Leksell GammaPlan is indicated for use in planning radiosurgical treatments for intracranial conditions such as tumors and arteriovenous malformations.
What outcomes have been reported in clinical studies?
Studies report effective dose calculation and treatment planning, with improved precision in radiosurgical interventions.
What complications have been reported?
Reported complications include integration challenges with certain imaging modalities, but no significant adverse events have been documented.
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.