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implantable electrode lead 030-272 using polyureth
Telectronics
Summary: The implantable electrode lead 030-272 by Telectronics is used in cardiac and neural applications. Key evidence highlights its role in managing congenital heart disease and challenges in elderly patients.
FDA Clearance Information
Pathway
510K
Number
K851294 ↗
Decision Date
April 10, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The implantable electrode lead 030-272 was cleared by the FDA via the 510(k) pathway on April 10, 1985. It is manufactured by Telectronics and classified as a Class III device.
What It Is
The implantable electrode lead 030-272 is designed for use in cardiac and neural applications, facilitating electrical stimulation and monitoring. It is intended for implantation in patients requiring long-term pacing or neural modulation.
Clinical Applications
Common clinical scenarios for this device include management of congenital heart disease and cardiac pacing in elderly patients. It is also used in deep brain stimulation for neurological conditions.
Evidence Summary
The literature includes 10 studies, ranging from 2021 to 2023, covering various study types such as RCTs and retrospective analyses. These studies explore the device's performance in cardiac and neural applications.
Reported Outcomes
Published studies report that the device is effective in managing congenital heart disease and provides reliable pacing in elderly patients. The multi-axes lead design enhances sensing and pacing capabilities. Neural applications show high spatial and temporal resolution.
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 monitoring.
Evidence Limitations
Evidence gaps include limited data on long-term outcomes and the influence of frailty on lead dislodgement. Further research is needed to optimize device design for neural applications and assess long-term safety.
Frequently Asked Questions
What are the clinical indications for implantable electrode lead 030-272?
The device is indicated for use in cardiac pacing and neural modulation, particularly in patients with congenital heart disease and those requiring deep brain stimulation.
What outcomes have been reported in clinical studies?
Studies report effective management of congenital heart disease and reliable pacing in elderly patients, with enhanced sensing and pacing capabilities in cardiac applications.
What complications have been reported?
Safety data indicate complications such as lead dislodgement in elderly patients and inflammatory responses in neural applications due to mechanical mismatch.
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.