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cyberknife system for stereotactic radiosurgery radiotherapy
Accuray
Summary: The CyberKnife System by Accuray is a robotic radiosurgery device primarily used for treating tumors with high precision. Key evidence highlights its efficacy in managing brain metastases and other tumors with minimal invasiveness.
FDA Clearance Information
Pathway
510K
Number
K052325 ↗
Decision Date
September 14, 2005
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The CyberKnife System was cleared by the FDA via the 510(k) pathway on September 14, 2005. It is manufactured by Accuray and classified as a Class 2 device under product code MUJ.
What It Is
The CyberKnife System is a robotic radiosurgery device designed for delivering precise radiation therapy to tumors. It is used in stereotactic radiosurgery and radiotherapy, offering a non-invasive alternative to traditional surgery.
Clinical Applications
The CyberKnife System is commonly used in the treatment of brain metastases, vestibular schwannomas, and other tumors requiring high precision. It is particularly useful in scenarios where traditional surgery is not feasible.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, prospective, and retrospective studies, published between 2023 and 2024. These studies evaluate the efficacy and safety of the CyberKnife System in various clinical settings.
Reported Outcomes
Published studies report that the CyberKnife System is effective in controlling tumor growth in conditions like brain metastases and vestibular schwannomas. It has shown promising results in maintaining hearing outcomes in patients with vestibular schwannomas and offers a minimally invasive treatment option for choroidal and ciliary body melanomas.
Safety Profile
Reported complications include deviations in haemostasis in cancer patients, which may affect therapeutic response. However, the overall safety profile is favorable, with minimal adverse events reported in the studies.
Evidence Limitations
Current evidence is limited by the small sample sizes and the need for longer follow-up periods to assess long-term outcomes. Further research is needed to establish standardized protocols and to explore the full range of clinical applications.
Frequently Asked Questions
What are the clinical indications for CyberKnife System?
The CyberKnife System is indicated for the treatment of brain metastases, vestibular schwannomas, and other tumors requiring precise radiation therapy.
What outcomes have been reported in clinical studies?
Studies have reported effective tumor control and favorable hearing outcomes in vestibular schwannoma patients, with minimal invasiveness.
What complications have been reported?
Safety data indicate deviations in haemostasis as a potential complication, but overall adverse events are minimal.
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.