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exactrac dynamic 2 0 exactrac dynamic surface
Brainlab Ag
Summary: ExacTrac Dynamic 2.0 by Brainlab Ag is a device for precise tumor ablation. It is primarily used in stereotactic radiosurgery (SRS) for brain metastases. Key evidence highlights its efficacy in local control of brain lesions.
FDA Clearance Information
Pathway
510K
Number
K240431 ↗
Decision Date
July 24, 2024
Product Code
IYE
Device Class
Class 2
Evidence
0 studies
The ExacTrac Dynamic 2.0 received FDA clearance via the 510(k) pathway on July 24, 2024. It is manufactured by Brainlab Ag and classified as a Class 2 device under product code IYE.
What It Is
The ExacTrac Dynamic 2.0 is a stereotactic radiosurgery device designed for precise tumor targeting and ablation. It integrates advanced imaging and surface guidance technologies to enhance treatment accuracy in clinical settings.
Clinical Applications
Commonly used in the treatment of brain metastases, the ExacTrac Dynamic 2.0 facilitates single-isocenter, multi-target dynamic conformal arc techniques. It is also employed in deep inspiration breath hold workflows for breast cancer patients.
Evidence Summary
The available literature includes four studies ranging from 2013 to 2025, encompassing various study types such as RCTs and prospective analyses. These studies focus on the device's application in stereotactic radiosurgery and quality assurance.
Reported Outcomes
Published studies report that the ExacTrac Dynamic 2.0 effectively maintains local control of brain metastases when used in single-isocenter dynamic conformal arc SRS. It also supports accurate patient positioning and breath hold monitoring in breast cancer treatments.
Safety Profile
Reported complications include potential neurocognitive toxicity associated with whole-brain radiation therapy, which the ExacTrac Dynamic 2.0 aims to mitigate through targeted treatment. No specific device-related adverse events are detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and lack of long-term follow-up data. Further research is needed to fully assess the device's safety profile and efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for ExacTrac Dynamic 2.0?
The device is indicated for use in stereotactic radiosurgery for brain metastases and in deep inspiration breath hold workflows for breast cancer patients.
What outcomes have been reported in clinical studies?
Studies report effective local control of brain metastases and accurate patient positioning for breast cancer treatments.
What complications have been reported?
Reported complications include potential neurocognitive toxicity from whole-brain radiation, which the device aims to reduce through precise targeting.
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.