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np bipolar endocardial lead w vs-1 connector
Biotronik Sales
Summary: The np bipolar endocardial lead with VS-1 connector by Biotronik Sales is a cardiac device used in pacing systems. It is primarily used by cardiologists for patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K875199 ↗
Decision Date
February 18, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The np bipolar endocardial lead was cleared via the FDA 510k pathway on February 18, 1988. Manufactured by Biotronik Sales, it is classified as a Class III device.
What It Is
The np bipolar endocardial lead is a component of cardiac pacing systems, designed to deliver electrical impulses to the heart muscle to maintain an adequate heart rate. It features a VS-1 connector, which is compatible with specific pacemaker models. This lead is typically used in patients with bradycardia or other conditions requiring pacing support.
Clinical Applications
This device is commonly used in cardiology, particularly in electrophysiology labs and cardiac surgery settings. It is suitable for patients with symptomatic bradycardia, heart block, or other rhythm disturbances that necessitate pacing. The lead is implanted endocardially, meaning it is placed inside the heart chambers, usually via a minimally invasive procedure.
Indications for Use
The np bipolar endocardial lead is indicated for patients who require cardiac pacing due to conditions like bradycardia or heart block. It helps maintain an appropriate heart rate by delivering electrical impulses directly to the heart muscle.
Practical Considerations
The lead is available in various lengths to accommodate different patient anatomies. It is important to ensure compatibility with the pacemaker generator being used. Implantation technique requires careful handling to avoid lead dislodgement and ensure optimal placement.
Frequently Asked Questions
What is np bipolar endocardial lead used for?
It is used for cardiac pacing in patients with conditions like bradycardia or heart block.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and cardiac surgery, typically use this device.
What are the FDA-cleared indications?
It is indicated for patients requiring cardiac pacing due to conditions such as 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.