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biotronik dn unipolar pe-60 4-dn
Biotronik Sales
Summary: The Biotronik DN Unipolar PE-60 4-DN is a Class III medical device used in cardiac pacing. It is typically utilized by cardiologists for patients requiring unipolar pacing leads.
FDA Clearance Information
Pathway
510K
Number
K833098 ↗
Decision Date
October 19, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Biotronik DN Unipolar PE-60 4-DN was cleared through the FDA 510(k) pathway on October 19, 1983. It is manufactured by Biotronik Sales and classified as a Class III device.
What It Is
The Biotronik DN Unipolar PE-60 4-DN is a unipolar pacing lead used in cardiac pacemakers. It functions by delivering electrical impulses to stimulate the heart muscle, ensuring proper heart rhythm. This device is essential in managing bradycardia and other rhythm disorders where the heart beats too slowly.
Clinical Applications
This device is commonly used in cardiology, particularly in electrophysiology labs and cardiac surgery settings. It is suitable for adult patients with conditions like bradycardia or heart block, where consistent pacing is required. The device is typically implanted during a pacemaker insertion procedure.
Indications for Use
The FDA indications suggest that this device is used for patients requiring cardiac pacing due to arrhythmias such as bradycardia. It is specifically indicated for use in unipolar pacing systems.
Practical Considerations
The Biotronik DN Unipolar PE-60 4-DN is compatible with most unipolar pacemakers. Clinicians should consider the lead's sizing and ensure proper placement to avoid lead dislodgement. Regular follow-up is necessary to monitor pacing thresholds and lead integrity.
Related Literature
The linked study examined the pacing impedance of various steroid-eluting leads compared to the Biotronik PE 60/4 DN lead. It found that the impedance of the Biotronik lead remained constant at shorter pulse durations but increased at longer durations. This suggests that the Biotronik lead may have higher polarization, which could affect pacing efficiency. Limitations include a small sample size and the study's focus on impedance rather than clinical outcomes.
Frequently Asked Questions
What is Biotronik DN Unipolar PE-60 4-DN used for?
It is used for cardiac pacing in patients with arrhythmias such as bradycardia.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology, use this device.
What are the FDA-cleared indications?
It is indicated for use in unipolar pacing systems for patients requiring cardiac pacing due to arrhythmias.
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.