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passive plus endocardial pacing leads var models
Siemens-Pacesetter
Summary: The Passive Plus Endocardial Pacing Leads are used in cardiac pacing procedures to help regulate heart rhythms. They are primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K932892 ↗
Decision Date
July 6, 1994
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Passive Plus Endocardial Pacing Leads by Siemens-Pacesetter were cleared through the FDA 510k pathway on July 6, 1994. It is a Class 3 medical device.
What It Is
The Passive Plus Endocardial Pacing Leads are implantable devices designed to deliver electrical impulses to the heart muscle to maintain an adequate heart rate. These leads are placed within the heart's endocardial surface and are connected to a pacemaker. They are critical in managing arrhythmias and ensuring proper cardiac function.
Clinical Applications
These pacing leads are commonly used in procedures to treat patients with bradycardia or other arrhythmias that require pacing support. Cardiologists and electrophysiologists typically use them in hospital settings, particularly in cardiac catheterization labs or during open-heart surgery. They are suitable for adult patients who require long-term pacing solutions.
Indications for Use
The FDA-cleared indications suggest that these leads are used for patients who need electrical stimulation of the heart to maintain a regular heartbeat. This includes conditions like bradycardia or heart block where the heart's natural pacing is insufficient.
Practical Considerations
The leads come in various lengths to accommodate different patient anatomies and are compatible with pacemakers that use a DF4 connector. Proper placement technique is crucial to ensure effective pacing and minimize complications.
Related Literature
The linked study evaluated the safety and electrical performance of INVICTA Leads Models equipped with a DF4 connector. Although the abstract is not available, such studies typically assess the reliability of electrical connections and the lead's performance over time. Limitations might include a lack of long-term data or a small sample size.
Frequently Asked Questions
What is Passive Plus Endocardial Pacing Leads used for?
They are used to deliver electrical impulses to the heart to maintain a regular heartbeat in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists in hospital settings use this device.
What are the FDA-cleared indications?
The device is indicated for patients needing electrical stimulation of the heart to maintain a regular heartbeat, such as those with 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.