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implantable electrode lead 030-270 using polyuret
Telectronics
Summary: The implantable electrode lead 030-270 by Telectronics is used in cardiac implantable electronic devices. It is FDA 510k cleared and linked to 10 studies, focusing on lead management and dislodgement.
FDA Clearance Information
Pathway
510K
Number
K851297 ↗
Decision Date
April 10, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The implantable electrode lead 030-270 by Telectronics was cleared through the FDA 510k pathway on April 10, 1985. It is classified as a Class 3 device.
What It Is
The implantable electrode lead 030-270 is designed for use in cardiac implantable electronic devices. It facilitates electrical conduction between the device and cardiac tissue, ensuring proper pacing and sensing.
Clinical Applications
Commonly used in patients requiring cardiac pacing, particularly in those with congenital heart disease or elderly patients at risk of lead dislodgement. It is crucial in managing cardiac rhythm disorders.
Evidence Summary
The literature includes 10 studies, ranging from 2018 to 2023, covering various study types such as RCTs and retrospective analyses. These studies focus on lead management, dislodgement, and technological advancements.
Reported Outcomes
Published studies report that the implantable electrode lead 030-270 is effective in maintaining cardiac rhythm and reducing complications related to lead dislodgement. The device shows promise in improving patient outcomes in both pediatric and elderly populations.
Safety Profile
Reported complications include lead dislodgement, particularly in elderly patients, and inflammatory responses due to mechanical mismatch in neural applications. Safety assessments emphasize the importance of evaluating patient-specific factors.
Evidence Limitations
Current evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to explore the device's performance in diverse patient populations and its long-term safety profile.
Frequently Asked Questions
What are the clinical indications for implantable electrode lead 030-270?
The device is indicated for use in patients requiring cardiac pacing, particularly those with congenital heart disease or at risk of lead dislodgement.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of cardiac rhythm and reduced lead dislodgement, with positive outcomes in both pediatric and elderly patients.
What complications have been reported?
Safety data indicate complications such as lead dislodgement and inflammatory responses, highlighting the need for careful patient evaluation.
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.