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unipolar bioplar implantable endocardial pacing leads with silicone rubber insulation passive fixation
Biotronik
Summary: The unipolar bipolar implantable endocardial pacing leads by Biotronik are used in cardiac pacing to manage arrhythmias. Cardiologists and electrophysiologists typically use these devices.
FDA Clearance Information
Pathway
510K
Number
K953044 ↗
Decision Date
September 27, 1996
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510k pathway on September 27, 1996. Manufactured by Biotronik, it is classified as a Class III device under product code DTB.
What It Is
The unipolar bipolar implantable endocardial pacing leads are designed for cardiac pacing, providing electrical stimulation to the heart muscle to maintain an adequate heart rate. These leads feature silicone rubber insulation and passive fixation, which helps secure the lead in place within the heart. The device is crucial for patients with bradycardia or other arrhythmias requiring pacing support.
Clinical Applications
These pacing leads are commonly used in procedures to implant pacemakers, particularly in patients with symptomatic bradycardia or heart block. They are typically used in cardiology and electrophysiology settings, often in hospital catheterization labs or specialized cardiac centers. The patient population includes adults and elderly patients who require long-term pacing solutions.
Indications for Use
The FDA indications suggest these leads are for patients who need cardiac pacing due to arrhythmias like bradycardia. They are suitable for individuals who require reliable heart rate management to prevent symptoms like dizziness or syncope.
Practical Considerations
These leads come in various lengths and configurations to accommodate different patient anatomies and pacing requirements. Compatibility with specific pacemaker models should be verified. Proper technique during implantation is crucial to ensure lead stability and function.
Frequently Asked Questions
What is unipolar bipolar implantable pacing leads used for?
They are used for cardiac pacing to manage arrhythmias such as bradycardia by providing electrical stimulation to the heart.
What specialties typically use this device?
Cardiology and electrophysiology specialists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to conditions like bradycardia or heart block.
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.