đź“‹ FDA Reference
implantable pacing leads w is-1 conn unipolar
Medtronic Vascular
Summary: Implantable pacing leads are used in cardiac pacing systems to deliver electrical impulses to the heart. They are primarily used by cardiologists and electrophysiologists to manage arrhythmias.
FDA Clearance Information
Pathway
510K
Number
K894040 ↗
Decision Date
July 14, 1989
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The implantable pacing leads with IS-1 connector by Medtronic Vascular were cleared through the FDA 510(k) pathway on July 14, 1989. This Class III device is designed for cardiac pacing applications.
What It Is
Implantable pacing leads are components of a cardiac pacing system, designed to transmit electrical impulses from a pacemaker to the heart muscle. These leads are unipolar, meaning they have a single electrode that contacts the heart tissue. The IS-1 connector standard ensures compatibility with most pacemakers. They are crucial for maintaining regular heart rhythms in patients with arrhythmias.
Clinical Applications
These leads are commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or heart block. They are typically utilized in hospital settings by cardiologists and electrophysiologists. The patient population includes those with symptomatic arrhythmias requiring pacing support.
Indications for Use
The FDA indications suggest these leads are intended for patients requiring cardiac pacing due to conditions like bradycardia or heart block. They help maintain adequate heart rates in patients whose hearts cannot do so naturally.
Practical Considerations
These leads are generally available in various lengths to accommodate different patient anatomies. They are designed to be compatible with pacemakers that use the IS-1 connector. Proper placement and secure fixation are critical to ensure effective pacing and minimize complications.
Frequently Asked Questions
What is implantable pacing leads used for?
They are used to deliver electrical impulses from a pacemaker to the heart to manage arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these devices in cardiac pacing procedures.
What are the FDA-cleared indications?
They are indicated for patients requiring cardiac pacing due to conditions like 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.