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biotronik endocardial pacing leads
Biotronik
Summary: Biotronik endocardial pacing leads are used for cardiac pacing. They are FDA-cleared and have been evaluated in multiple studies. Key findings include concerns about lead integrity and safety in specific pacing scenarios.
FDA Clearance Information
Pathway
510K
Number
K061212 ↗
Decision Date
July 10, 2006
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Biotronik endocardial pacing leads were cleared by the FDA via the 510k pathway on July 10, 2006. Manufactured by Biotronik, they are classified as Class 3 devices.
What It Is
Biotronik endocardial pacing leads are devices used to deliver electrical impulses to the heart to maintain an adequate heart rate. They are intended for use in patients requiring cardiac pacing due to arrhythmias or heart block.
Clinical Applications
These leads are commonly used in patients with bradycardia or heart block who require pacing to maintain heart function. They are also utilized in cardiac resynchronization therapy for heart failure patients.
Evidence Summary
The available literature includes 12 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series. The studies span from 2020 to 2025, providing a comprehensive overview of the device's performance.
Reported Outcomes
Published studies report that Biotronik endocardial pacing leads are effective in maintaining cardiac rhythm in patients with arrhythmias. The LIFE-LBBAP study highlights concerns about lead integrity in left bundle branch area pacing. Other studies focus on the device's role in cardiac resynchronization therapy.
Safety Profile
Reported complications include issues with lead integrity and potential electromagnetic interference, particularly in patients with mechanical prosthetic valves. These safety concerns necessitate careful consideration during device implantation and follow-up.
Evidence Limitations
The evidence is limited by the lack of long-term follow-up data and the need for more studies focusing on specific patient populations, such as those with mechanical prosthetic valves. Further research is needed to address these gaps and optimize device performance.
Frequently Asked Questions
What are the clinical indications for Biotronik endocardial pacing leads?
Biotronik endocardial pacing leads are indicated for patients requiring cardiac pacing due to arrhythmias or heart block.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of cardiac rhythm and highlight concerns about lead integrity in specific pacing scenarios.
What complications have been reported?
Safety data indicate complications such as lead integrity issues and potential electromagnetic interference in certain patients.
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.