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endocardial leads-mod to the polyvinylpyrrolidone
Pacesetter Systems
Summary: The endocardial leads-mod to the polyvinylpyrrolidone by Pacesetter Systems are used in cardiac pacing systems. They are primarily utilized by cardiologists for patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K910924 ↗
Decision Date
August 28, 1991
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on August 28, 1991. Manufactured by Pacesetter Systems, it is classified as a Class III device under product code DTB.
What It Is
Endocardial leads-mod to the polyvinylpyrrolidone are specialized leads used in cardiac pacing systems. These leads are designed to be implanted within the heart's endocardial surface to deliver electrical impulses that help regulate heartbeats. The polyvinylpyrrolidone modification enhances the biocompatibility and stability of the leads, ensuring effective long-term performance.
Clinical Applications
These leads are commonly used in procedures involving the implantation of pacemakers or implantable cardioverter-defibrillators (ICDs). Cardiologists and electrophysiologists typically use them in hospital settings, particularly in cardiac catheterization labs. They are suitable for patients with arrhythmias or heart block who require consistent cardiac pacing.
Indications for Use
The FDA indications suggest that these leads are intended for patients who need cardiac rhythm management. This includes individuals with conditions like bradycardia or heart block, where the heart beats too slowly or irregularly.
Practical Considerations
When using these leads, clinicians should consider the appropriate lead length and diameter to match patient anatomy. Compatibility with existing pacemaker or ICD systems is crucial, and proper implantation technique is essential to minimize complications such as lead dislodgement or infection.
Frequently Asked Questions
What is endocardial leads-mod to the polyvinylpyrrolidone used for?
These leads are used in cardiac pacing systems to help regulate heartbeats in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings, especially in cardiac catheterization labs.
What are the FDA-cleared indications?
The device is indicated for patients needing cardiac rhythm management, 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.