📋 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 ?
510(k)
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.
FDA-Cleared Indications
- Use as an implantable cardiac pacing lead with a compatible pacemaker system.
- Use in patients who require cardiac pacing for clinically significant slow heart rates or conduction disorders, according to the applicable pacemaker system labeling.
Clinical Applications
- Permanent cardiac pacing for patients with bradycardia or heart block when a pacemaker is indicated.
- Placement of a straight-tined lead or J-shaped tined lead according to cardiac anatomy and the physician's pacing strategy.
- Connection to a compatible implanted pacemaker generator to deliver electrical impulses to the heart.
Practical Considerations
- The device family includes straight-tined UT46 and BT45 leads and J-shaped UJ45 and BJ44 leads; the listed model numbers indicate nominal lead sizes of approximately 46 or 45, respectively.
- The lead must be used with a compatible pacemaker system and implanted by trained cardiac electrophysiology or cardiology personnel.
- Tined leads are positioned within the heart to help maintain fixation; careful placement and electrical testing are required before final connection.
- MRI safety is not established from the information provided. Do not assume the lead is MRI-conditional; confirm the exact lead, generator, and current manufacturer or FDA labeling before MRI.
- Potential complications include lead displacement, failure to capture or sense, fracture, insulation damage, infection, venous obstruction, heart perforation, and arrhythmia.
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.