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modified j-stiffener wire material in lead lines
Telectronics Pacing Systems
Summary: The modified j-stiffener wire material is used in lead lines, primarily for pacing systems. Key evidence highlights its role in maintaining wire tension and stability, crucial for clinical applications.
FDA Clearance Information
Pathway
510K
Number
K897067 ↗
Decision Date
February 5, 1990
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on February 5, 1990. It is manufactured by Telectronics Pacing Systems and classified as a Class 3 device.
What It Is
The modified j-stiffener wire material is designed for use in lead lines, providing structural support and stability. It is intended to enhance the performance of pacing systems by maintaining proper wire tension.
Clinical Applications
This device is commonly used in scenarios requiring reliable lead line stability, such as in the placement of pacing systems. It is crucial in ensuring the correct positioning and function of the leads.
Evidence Summary
The literature includes 10 studies, encompassing various study types such as RCTs and case series, published between 2022 and 2025. These studies explore different aspects of wire material applications and modifications.
Reported Outcomes
Published studies report that the modified j-stiffener wire material effectively maintains wire tension, which is critical for the stability of constructs in clinical applications. The evidence suggests its utility in enhancing procedural outcomes.
Safety Profile
Reported complications include potential inaccuracies in wire tensioning when non-calibrated methods are used, as highlighted in the studies. However, specific adverse events related to the device itself were not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of direct studies on the specific device, with most research focusing on related wire materials and applications. Further research is needed to directly assess the device's long-term safety and efficacy.
Frequently Asked Questions
What are the clinical indications for modified j-stiffener wire material?
The device is indicated for use in lead lines, particularly in pacing systems, to ensure stability and proper tension.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of wire tension, crucial for the stability and performance of pacing systems.
What complications have been reported?
Safety data indicate potential inaccuracies in wire tensioning with non-calibrated methods, but specific device-related complications were not detailed.
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.