đź“Š Evidence-Based Reference
leksell gammaplan
Elekta Instrument Ab
Summary: Leksell GammaPlan is a treatment planning system for Gamma Knife radiosurgery, primarily used for precise targeting of brain lesions. Key evidence highlights its efficacy in dose calculation and treatment planning.
FDA Clearance Information
Pathway
510K
Number
K103093 ↗
Decision Date
December 21, 2010
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Leksell GammaPlan was cleared by the FDA via the 510(k) pathway on December 21, 2010. It is manufactured by Elekta Instrument Ab and classified as a Class 2 medical device.
What It Is
Leksell GammaPlan is a software system designed for planning radiosurgical treatments using the Gamma Knife. It enables clinicians to create precise treatment plans for targeting brain lesions with high-dose radiation.
Clinical Applications
Commonly used in the treatment of brain tumors, arteriovenous malformations, and other intracranial conditions, Leksell GammaPlan facilitates accurate dose delivery in radiosurgery, enhancing treatment precision and patient outcomes.
Evidence Summary
The available literature includes 12 studies, comprising various study types such as RCTs, prospective, and retrospective studies, published between 2020 and 2023.
Reported Outcomes
Published studies report that Leksell GammaPlan effectively supports precise dose calculations and treatment planning in Gamma Knife radiosurgery. It has been shown to improve the accuracy of targeting brain lesions, contributing to successful clinical outcomes.
Safety Profile
Reported complications include potential inaccuracies in dose delivery due to volume averaging and fixation stability issues. However, these are generally manageable with proper technique and equipment calibration.
Evidence Limitations
Current evidence is limited by the small number of large-scale RCTs and the need for more longitudinal studies to assess long-term outcomes. Further research is needed to explore the full scope of clinical applications and potential improvements in safety protocols.
Frequently Asked Questions
What are the clinical indications for Leksell GammaPlan?
Leksell GammaPlan is indicated for planning radiosurgical treatments of brain tumors, arteriovenous malformations, and other intracranial conditions.
What outcomes have been reported in clinical studies?
Studies have reported improved accuracy in dose delivery and successful targeting of brain lesions, contributing to positive treatment outcomes.
What complications have been reported?
Safety data indicate potential complications such as dose delivery inaccuracies and fixation stability issues, which are generally manageable with proper techniques.
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.