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biotronik n bipolar peb-60 4-n
Biotronik Sales
Summary: The Biotronik N Bipolar PEB-60 4-N is a Class III medical device used in cardiovascular procedures, specifically for intracardiac applications. It is typically used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K833099 ↗
Decision Date
October 20, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Biotronik N Bipolar PEB-60 4-N was cleared through the FDA 510k pathway on October 20, 1983. Manufactured by Biotronik Sales, it is classified as a Class III device.
What It Is
The Biotronik N Bipolar PEB-60 4-N is a bipolar pacing lead used in cardiac procedures. It is designed to deliver electrical impulses to the heart to maintain an adequate heart rate, particularly in patients with arrhythmias. The bipolar design allows for more precise signal delivery and reduced interference, which is critical in managing complex cardiac conditions.
Clinical Applications
This device is primarily used in electrophysiology labs and cardiac catheterization labs. It is employed in procedures involving cardiac pacing, particularly in patients with bradycardia or heart block. Cardiologists and electrophysiologists use this device in both inpatient and outpatient settings to ensure effective heart rhythm management.
Indications for Use
The device is indicated for use in patients requiring cardiac pacing due to conditions like bradycardia or heart block. It helps maintain proper heart rhythm by delivering electrical impulses directly to the heart tissue.
Practical Considerations
The Biotronik N Bipolar PEB-60 4-N is compatible with various pacemaker systems. Clinicians should ensure proper lead placement and secure connections to avoid dislodgement. Familiarity with the device's handling and insertion technique is essential for optimal performance.
Related Literature
The linked study investigated the efficacy of scar homogenization in VT patients with ischemic cardiomyopathy. It compared outcomes of combined epicardial and endocardial ablation versus endocardial-only ablation over a five-year period. The study found that combined ablation may offer better long-term outcomes, but limitations include its focus on a specific patient group and the need for further research to generalize findings.
Frequently Asked Questions
What is Biotronik N Bipolar PEB-60 4-N used for?
It is used for cardiac pacing in patients with arrhythmias, such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device in cardiac procedures.
What are the FDA-cleared indications?
It is indicated for use in patients requiring cardiac pacing to manage heart rhythm disorders.
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.