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implantable electrode lead 030-269 using polyureth
Telectronics
Summary: The implantable electrode lead 030-269 by Telectronics is used in cardiac and neural applications. Key evidence highlights its role in pacing and sensing technology, with studies focusing on lead dislodgement and electrode-tissue interfaces.
FDA Clearance Information
Pathway
510K
Number
K851296 ↗
Decision Date
April 11, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The implantable electrode lead 030-269 was cleared through the FDA 510(k) pathway on April 11, 1985. It is manufactured by Telectronics and classified as a Class III device.
What It Is
The implantable electrode lead 030-269 is designed for use in cardiac and neural applications, facilitating electrical stimulation and signal recording. It is intended for implantation in patients requiring cardiac pacing or neural modulation.
Clinical Applications
Commonly used in patients with cardiac arrhythmias or neurological disorders, the device aids in managing heart rhythm and neural activity. It is particularly relevant in scenarios requiring precise electrical stimulation.
Evidence Summary
The literature includes 10 studies, ranging from 2021 to 2023, covering various study types such as RCTs, prospective, and retrospective analyses. These studies explore device performance, safety, and clinical outcomes.
Reported Outcomes
Published studies report that the device effectively supports pacing and sensing in cardiac applications, with innovative designs like the tetrahedral electrode tip enhancing performance. In neural applications, it provides high-resolution recording and stimulation capabilities.
Safety Profile
Reported complications include lead dislodgement, particularly in elderly patients, and inflammatory responses due to mechanical mismatch in neural applications. These issues highlight the importance of careful patient selection and device handling.
Evidence Limitations
Evidence gaps include limited long-term data on device performance and safety. Further research is needed to explore the impact of frailty on lead dislodgement and to optimize electrode-tissue interfaces in neural applications.
Frequently Asked Questions
What are the clinical indications for implantable electrode lead 030-269?
The device is indicated for use in cardiac pacing and neural modulation, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
Studies report effective pacing and sensing, with innovative electrode designs improving performance.
What complications have been reported?
Safety data indicate risks of lead dislodgement and inflammatory responses in neural applications.
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.