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lead pacing atrial endocardial tined
Medtronic Vascular
Summary: The lead pacing atrial endocardial tined is a device used for cardiac pacing, primarily in patients requiring atrial pacing. Key evidence highlights its stability and challenges in extraction.
FDA Clearance Information
Pathway
510K
Number
K780621 ↗
Decision Date
July 26, 1978
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared by the FDA through the 510(k) pathway on July 26, 1978. It is manufactured by Medtronic Vascular and classified as a Class 3 medical device.
What It Is
The lead pacing atrial endocardial tined is designed for cardiac pacing, utilizing tines for fixation to the endocardium. It is intended for use in patients requiring atrial pacing to manage arrhythmias.
Clinical Applications
Commonly used in scenarios requiring atrial pacing, such as in patients with bradyarrhythmias or atrial standstill. It provides a reliable method for maintaining cardiac rhythm.
Evidence Summary
The literature includes 7 studies, encompassing various study types such as RCTs and case series, with publication dates ranging from 1984 to 2008. These studies provide insights into device outcomes and safety.
Reported Outcomes
Published studies report that the use of tined leads has decreased dislodgment rates. In canine models, survival after pacemaker implantation varied, with some dogs living up to 42 months post-implantation. The stability of dual-chamber pacing electrodes during CPR was also noted.
Safety Profile
Reported complications include lead dislodgement, with varying occurrences between tined and untined leads. Other complications noted were infection and hematoma formation.
Evidence Limitations
The evidence is limited by the small number of studies directly addressing the device's use in humans. Further research is needed to explore long-term outcomes and complications in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for lead pacing atrial endocardial tined?
The device is indicated for patients requiring atrial pacing, such as those with bradyarrhythmias or atrial standstill.
What outcomes have been reported in clinical studies?
Studies have reported decreased dislodgment rates and variable survival outcomes in animal models, with some living up to 42 months post-implantation.
What complications have been reported?
Safety data indicate complications such as lead dislodgement, infection, and hematoma formation.
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.