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electrodes implantable with adapter
Telectronics
Summary: The implantable electrodes with adapter by Telectronics are used in interfacing neuron-motor pathways and deep brain stimulation. Key evidence highlights their role in precise stimulation and potential safety in mixed device use.
FDA Clearance Information
Pathway
510K
Number
K781849 ↗
Decision Date
December 4, 1978
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The electrodes implantable with adapter by Telectronics were cleared through the FDA 510k pathway on December 4, 1978. They are classified as Class 3 medical devices.
What It Is
These implantable electrodes are designed to interface with neuron-motor pathways, allowing for precise electrical stimulation in clinical settings. They are intended for use in procedures requiring high-density electrode arrays.
Clinical Applications
Commonly used in deep brain stimulation and interfacing neuron-motor pathways, these electrodes are crucial in scenarios requiring precise electrical signal transmission, such as in movement disorder treatments.
Evidence Summary
The available literature includes 11 studies, with types ranging from RCTs to case series, published between 2023 and 2024. These studies explore the device's efficacy and safety in various clinical applications.
Reported Outcomes
Published studies report that the electrodes provide precise stimulation in deep brain stimulation and effective interfacing in neuron-motor pathways. The use of adapters allows for compatibility with different device brands, enhancing their versatility in clinical practice.
Safety Profile
Reported complications include potential issues with impedance when switching from constant voltage to constant current in deep brain stimulation. However, the use of proper adapters mitigates these risks, ensuring safe device operation.
Evidence Limitations
Current evidence is limited by the short duration of studies and the need for larger sample sizes to confirm findings. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for electrodes implantable with adapter?
The clinical indications include interfacing neuron-motor pathways and use in deep brain stimulation for movement disorders.
What outcomes have been reported in clinical studies?
Studies report precise stimulation capabilities and effective interfacing with neuron-motor pathways, with adapters enhancing device compatibility.
What complications have been reported?
Safety data indicates potential impedance issues when switching stimulation modes, but these are mitigated by using appropriate adapters.
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.