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permanent cardiac pacing leads and adaptors
Medtronic Vascular
Summary: Permanent cardiac pacing leads are used for managing bradyarrhythmias. Key evidence suggests alternative lead positioning may improve cardiac function.
FDA Clearance Information
Pathway
510K
Number
K912464 ↗
Decision Date
February 11, 1992
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on February 11, 1992, by Medtronic Vascular. It is classified as a Class 3 medical device.
What It Is
Permanent cardiac pacing leads are designed to deliver electrical impulses to the heart to maintain an adequate heart rate in patients with bradyarrhythmias. These leads are typically implanted in the right ventricle and are used in conjunction with a pacemaker device.
Clinical Applications
These leads are commonly used in patients with symptomatic bradyarrhythmias, including those with sick sinus syndrome or atrioventricular block. They are essential in maintaining cardiac output and preventing syncope or heart failure.
Evidence Summary
The literature includes 13 studies, comprising RCTs, prospective, and retrospective analyses, published between 2019 and 2024. These studies explore various aspects of pacing lead performance and outcomes.
Reported Outcomes
Published studies report that alternative lead positioning, such as in the right ventricular outflow tract, may improve electromechanical synchrony and cardiac function. Chronic right ventricular pacing has been associated with cardiomyopathy and heart failure in some patients.
Safety Profile
Reported complications include ventricular dyssynchrony and reduced cardiac function associated with chronic right ventricular pacing. Lead-related complications are a significant concern in traditional transvenous pacemaker systems.
Evidence Limitations
Current evidence is limited by the heterogeneity of study designs and patient populations. Further research is needed to explore long-term outcomes and the efficacy of alternative lead positioning strategies.
Frequently Asked Questions
What are the clinical indications for permanent cardiac pacing leads?
Permanent cardiac pacing leads are indicated for patients with symptomatic bradyarrhythmias, such as sick sinus syndrome and atrioventricular block.
What outcomes have been reported in clinical studies?
Studies have reported improved cardiac function with alternative lead positioning and identified risks of cardiomyopathy with chronic right ventricular pacing.
What complications have been reported?
Safety data indicate complications such as ventricular dyssynchrony and reduced cardiac function, particularly with chronic right ventricular pacing.
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.