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polysafe implant pacing leads w trabeculok tip
Cardiac Control Systems
Summary: The Polysafe Implant Pacing Leads are used in cardiac pacing procedures to maintain heart rhythm. They are typically used by cardiologists in hospital settings for patients requiring pacemaker implantation.
FDA Clearance Information
Pathway
510K
Number
K883015 ↗
Decision Date
October 6, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Polysafe Implant Pacing Leads were cleared through the FDA 510(k) pathway on October 6, 1988. Manufactured by Cardiac Control Systems, this Class 3 device is essential in cardiac pacing.
What It Is
The Polysafe Implant Pacing Leads are specialized leads used in cardiac pacemaker systems. They are designed to deliver electrical impulses from the pacemaker to the heart muscle, ensuring proper heart rhythm. The Trabeculok tip enhances stability and reduces the risk of lead dislodgement, making it a reliable option for long-term pacing.
Clinical Applications
These leads are commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or heart block. Cardiologists and electrophysiologists typically perform these procedures in hospital cardiac units. The device is suitable for adult and elderly patients who require consistent heart rhythm management.
Indications for Use
The Polysafe Implant Pacing Leads are indicated for patients who need cardiac pacing due to conditions like slow heart rate or heart block. They are used in conjunction with pacemakers to ensure the heart maintains a regular rhythm.
Practical Considerations
The leads are available in various lengths to accommodate different patient anatomies and are compatible with most modern pacemaker systems. Proper implantation technique is crucial to ensure optimal performance and longevity of the device.
Frequently Asked Questions
What is Polysafe Implant Pacing Leads used for?
They are used for cardiac pacing to maintain heart rhythm in patients with conditions like bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac units of hospitals.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to slow heart rate 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.