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leksell gammaplan
Elekta Instrument Ab
Summary: Leksell GammaPlan is a treatment planning system used in radiosurgery, primarily for brain conditions. Key evidence highlights its efficacy in dose calculation and treatment planning.
FDA Clearance Information
Pathway
510K
Number
K151666 ↗
Decision Date
September 3, 2015
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Leksell GammaPlan was cleared by the FDA via the 510(k) pathway on September 3, 2015. It is manufactured by Elekta Instrument Ab and classified as a Class 2 device.
What It Is
The Leksell GammaPlan is a sophisticated treatment planning system designed for use in stereotactic radiosurgery, particularly with the Leksell Gamma Knife. It allows clinicians to plan precise radiation doses for treating brain disorders.
Clinical Applications
Commonly used in the treatment of brain tumors, arteriovenous malformations, and functional disorders, the Leksell GammaPlan facilitates accurate dose planning to target specific areas within the brain while minimizing exposure to surrounding healthy tissue.
Evidence Summary
The available literature includes 12 studies, comprising various study types such as RCTs and retrospective analyses, published between 2020 and 2023. These studies focus on the system's efficacy and integration with imaging modalities.
Reported Outcomes
Published studies report that the Leksell GammaPlan is effective in improving dose calculation accuracy and treatment planning efficiency. It has been shown to enhance the precision of radiosurgical interventions, particularly in complex cases involving brain metastases and aneurysms.
Safety Profile
Reported complications include challenges in integrating certain imaging modalities with the system, which may affect treatment planning. However, no significant adverse events directly related to the device's use have been documented in the provided studies.
Evidence Limitations
Current evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to explore long-term outcomes and the integration of newer imaging technologies with the Leksell GammaPlan.
Frequently Asked Questions
What are the clinical indications for Leksell GammaPlan?
The Leksell GammaPlan is indicated for use in stereotactic radiosurgery for conditions such as brain tumors, arteriovenous malformations, and functional disorders.
What outcomes have been reported in clinical studies?
Studies have reported improved dose calculation accuracy and treatment planning efficiency, particularly in complex cases involving brain metastases and aneurysms.
What complications have been reported?
Reported complications include integration challenges with certain imaging modalities, but no significant adverse events directly related to the device's use 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.