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lead tined pacing implantable
Daig
Summary: The lead tined pacing implantable by Daig is a device used for cardiac pacing. It is FDA-cleared and supported by 10 studies, highlighting its clinical use and safety profile.
FDA Clearance Information
Pathway
510K
Number
K800354 ↗
Decision Date
May 30, 1980
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The lead tined pacing implantable was cleared by the FDA through the 510k pathway on May 30, 1980. It is manufactured by Daig and classified as a Class 3 device.
What It Is
The lead tined pacing implantable is a cardiac device designed to provide pacing to the heart. It uses tined leads to ensure stable positioning within the heart, facilitating effective electrical stimulation for patients with arrhythmias.
Clinical Applications
This device is commonly used in patients requiring ventricular pacing due to arrhythmias or heart block. It is particularly useful in scenarios where stable lead placement is critical for effective pacing.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and case series, conducted between 1997 and 2006. These studies provide insights into the device's performance and safety.
Reported Outcomes
Published studies report that the lead tined pacing implantable demonstrates effective pacing with stable chronic pulse width thresholds and pacing impedances. Electrogram amplitudes were also found to be within acceptable ranges, indicating reliable device performance.
Safety Profile
Reported complications include lead failures due to manufacturing errors, such as short-circuited conductors. Some studies noted increased lead failure rates with certain high-impedance models.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to assess long-term outcomes and to compare performance with newer pacing technologies.
Frequently Asked Questions
What are the clinical indications for lead tined pacing implantable?
The device is indicated for patients requiring ventricular pacing due to arrhythmias or heart block, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
Studies report effective pacing with stable chronic pulse width thresholds and pacing impedances, as well as reliable electrogram amplitudes.
What complications have been reported?
Safety data indicate lead failures due to manufacturing errors and increased failure rates in certain high-impedance models.
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.