đź“‹ FDA Reference
stela ut46 and bt45 46 straight tined pacing leads stela uj45 and bj44 45 j-shaped tined pacing leads
Ela Medical
Summary: The Stela pacing leads are implantable devices used for cardiac pacing. They are utilized by cardiologists for patients requiring heart rhythm management.
FDA Clearance Information
Pathway
510K
Number
K000029 ↗
Decision Date
April 4, 2000
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Stela pacing leads were cleared via the FDA 510k pathway on April 4, 2000. Manufactured by Ela Medical, these devices are classified as Class III.
What It Is
The Stela pacing leads, available in straight and J-shaped tined configurations, are designed for cardiac pacing. These leads are implanted in the heart to deliver electrical impulses that regulate heartbeats. The tined design helps secure the lead in place within the heart tissue, ensuring effective pacing.
Clinical Applications
These pacing leads are commonly used in procedures for patients with bradycardia or other arrhythmias requiring pacing. Cardiologists in hospital settings typically perform these implantations. They are suitable for adult patients who need long-term heart rhythm management.
Indications for Use
The FDA indications suggest that these leads are intended for patients with conditions that necessitate cardiac pacing, such as slow heart rates or heart block. They help maintain adequate heart rhythm and cardiac output.
Practical Considerations
The Stela leads come in different shapes to accommodate anatomical variations and physician preference. They are compatible with standard pacemaker systems, and proper placement technique is crucial for optimal performance.
Frequently Asked Questions
What is Stela pacing leads used for?
Stela pacing leads are used for cardiac pacing in patients with arrhythmias that require heart rhythm management.
What specialties typically use this device?
Cardiologists typically use these devices, particularly those specializing in electrophysiology and cardiac rhythm management.
What are the FDA-cleared indications?
These leads are indicated for patients needing 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.