đź“Š Evidence-Based Reference
implantable electrode lead 030-271 using polyureth
Telectronics
Summary: The implantable electrode lead 030-271 by Telectronics is used in cardiac and neural applications. It was FDA-cleared in 1985. Key evidence highlights its use in managing congenital heart disease and neural electrode-tissue interfaces.
FDA Clearance Information
Pathway
510K
Number
K851295 ↗
Decision Date
April 10, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The implantable electrode lead 030-271 was cleared by the FDA via the 510k pathway on April 10, 1985. Manufactured by Telectronics, it is classified as a Class 3 device.
What It Is
The implantable electrode lead 030-271 is designed for use in cardiac and neural applications, facilitating electrical stimulation and signal recording. It is intended for implantation in patients requiring long-term pacing or neural modulation.
Clinical Applications
Commonly used in patients with congenital heart disease and those requiring deep brain stimulation, the device is integral in managing complex cardiac and neural conditions. It is particularly relevant in scenarios involving pacing and sensing technology.
Evidence Summary
The literature includes 10 studies ranging from 2021 to 2023, encompassing various study types such as RCTs, prospective, and retrospective analyses. These studies explore the device's performance in cardiac and neural applications.
Reported Outcomes
Published studies report the device's efficacy in managing congenital heart disease and enhancing neural electrode-tissue interfaces. The multi-axes lead design improves pacing and sensing capabilities, while implant-friendly MRI strategies mitigate RF heating in deep brain stimulation applications.
Safety Profile
Reported complications include lead dislodgement, particularly in elderly patients, and inflammatory responses due to mechanical mismatch in neural applications. These findings highlight the importance of careful patient selection and procedural planning.
Evidence Limitations
Current evidence is limited by small sample sizes and a focus on specific patient populations. Further research is needed to explore long-term outcomes and broader applicability across diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for implantable electrode lead 030-271?
The device is indicated for use in patients requiring cardiac pacing and neural modulation, particularly in congenital heart disease and deep brain stimulation.
What outcomes have been reported in clinical studies?
Studies report improved pacing and sensing capabilities, as well as effective management of congenital heart disease and neural electrode-tissue interfaces.
What complications have been reported?
Safety data indicate risks of lead dislodgement and inflammatory responses, necessitating careful patient selection and procedural planning.
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.