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pacing leads guide wires and various accessories
Biotronik
Summary: Pacing leads guide wires and accessories by Biotronik are used for cardiac pacing. Cleared by FDA via 510k pathway. Evidence includes studies on venous stenosis management and lead placement techniques.
FDA Clearance Information
Pathway
510K
Number
K003072 ↗
Decision Date
January 9, 2001
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared by the FDA through the 510k pathway on January 9, 2001. It is manufactured by Biotronik and classified as a Class 3 medical device.
What It Is
Pacing leads guide wires and accessories are used in cardiac pacing procedures. They facilitate the placement and function of pacemaker leads, ensuring proper cardiac rhythm management.
Clinical Applications
These devices are commonly used in scenarios requiring cardiac pacing, such as managing arrhythmias or heart block. They are integral in procedures involving pacemaker or defibrillator lead placement.
Evidence Summary
The available literature includes 9 studies, with types ranging from RCTs to case series. The studies span from 2023 to 2025, focusing on lead placement techniques and associated complications.
Reported Outcomes
Published studies report on the efficacy of pacing leads in managing venous stenosis and facilitating left bundle branch area pacing. The use of multiple electrode leads has shown potential in improving pacing outcomes.
Safety Profile
Reported complications include venous stenosis secondary to lead placement and potential perforation of cardiac structures. These events highlight the need for careful procedural planning and execution.
Evidence Limitations
The evidence is limited by the small number of studies and the variability in study design. Further research is needed to establish long-term outcomes and optimize lead placement techniques.
Frequently Asked Questions
What are the clinical indications for pacing leads guide wires and accessories?
These devices are indicated for use in cardiac pacing procedures, particularly in managing arrhythmias and ensuring proper pacemaker lead placement.
What outcomes have been reported in clinical studies?
Studies have reported improved management of venous stenosis and enhanced pacing outcomes with the use of multiple electrode leads.
What complications have been reported?
Safety data indicate complications such as venous stenosis and potential cardiac perforation during lead placement.
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.