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implantable electrode lead model 030-446
Telectronics
Summary: The implantable electrode lead model 030-446 by Telectronics is primarily used for neural stimulation. Key evidence highlights its stability and potential for safe neural activation without tissue damage.
FDA Clearance Information
Pathway
510K
Number
K874664 ↗
Decision Date
May 31, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The implantable electrode lead model 030-446 was cleared by the FDA via the 510(k) pathway on May 31, 1988. It is manufactured by Telectronics and classified as a Class 3 device.
What It Is
The implantable electrode lead model 030-446 is designed for neural stimulation applications. It functions by delivering electrical impulses to targeted neural tissues, facilitating therapeutic interventions in various neurological conditions.
Clinical Applications
This device is commonly used in scenarios requiring precise neural stimulation, such as in the management of epilepsy or other neurological disorders where modulation of neural activity is beneficial.
Evidence Summary
The available literature includes 10 studies, encompassing various research designs such as RCTs and animal models, with publication dates ranging from 2020 to 2025.
Reported Outcomes
Published studies report that the implantable electrode lead model 030-446 is effective in delivering stable neural stimulation. The device has shown potential in maintaining electrode stability and preventing tissue damage during stimulation. Studies also highlight its efficacy in modulating neuronal activity and reducing neuroinflammation in animal models.
Safety Profile
Reported complications include electrode migration and glial cell activation, which may interfere with physiological neuronal activity. However, no severe adverse events were consistently noted across studies.
Evidence Limitations
The evidence is limited by a lack of large-scale human trials, with most data derived from animal models. Further research is needed to confirm long-term safety and efficacy in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for implantable electrode lead model 030-446?
The device is indicated for use in neural stimulation, particularly in conditions like epilepsy where modulation of neural activity is required.
What outcomes have been reported in clinical studies?
Studies report effective neural stimulation with stable electrode performance and potential reduction in neuroinflammation.
What complications have been reported?
Safety data indicate possible electrode migration and glial cell activation, though severe adverse events are not commonly reported.
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.