đź“Š Evidence-Based Reference
bipolar implantable endocardial pacing leads with silicone rubber insulation and passive fixation
Biotronik
Summary: Bipolar implantable endocardial pacing leads with silicone rubber insulation and passive fixation are used for cardiac pacing. Cleared by the FDA in 1997, these leads are primarily used in patients requiring cardiac pacing. Key evidence highlights improvements in lead reliability and alternative pacing strategies.
FDA Clearance Information
Pathway
510K
Number
K964604 ↗
Decision Date
March 10, 1997
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on March 10, 1997, by Biotronik. It is classified as a Class III device under product code DTB.
What It Is
The device is a bipolar implantable endocardial pacing lead with silicone rubber insulation designed for passive fixation. It is used in cardiac pacing to manage heart rhythm disorders by delivering electrical impulses to the heart muscle.
Clinical Applications
These pacing leads are commonly used in patients with heart block or other cardiac conduction disorders requiring pacing. They are particularly relevant in scenarios where endocardial pacing is indicated, such as in patients with congenital heart disease or limited venous access.
Evidence Summary
The literature includes 12 studies, encompassing randomized controlled trials, prospective, retrospective, and case series designs. The studies span from 2001 to 2023, focusing on pacing lead performance, alternative pacing strategies, and long-term outcomes.
Reported Outcomes
Published studies report improvements in the reliability of bipolar pacing leads over time. Alternative pacing strategies, such as epicardial pacing, have been explored to address specific clinical challenges. The evidence suggests that bipolar leads offer effective pacing and sensing characteristics.
Safety Profile
Reported complications include potential lead dislodgement and insulation failure. However, recent advancements have improved the durability and performance of these leads, reducing the incidence of such adverse events.
Evidence Limitations
The evidence is limited by the variability in study designs and patient populations. Further research is needed to explore long-term outcomes and the comparative effectiveness of different pacing strategies in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for bipolar implantable endocardial pacing leads?
These leads are indicated for patients requiring cardiac pacing, particularly those with heart block or congenital heart disease.
What outcomes have been reported in clinical studies?
Studies report improved reliability and effective pacing and sensing characteristics of bipolar leads.
What complications have been reported?
Reported complications include lead dislodgement and insulation failure, though advancements have reduced these risks.
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.