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stela ut46 and bt45 46 straight tined pacing leads stela uj45 and bj44 45 j-shaped tined pacing leads
Ela Medical
Summary: The Stela UT46/BT45 and UJ45/BJ44 are pacing leads by Ela Medical, used in cardiac pacing procedures. They are utilized by cardiologists and electrophysiologists for patients requiring pacemaker implantation.
FDA Clearance Information
Pathway 510K
Number K993448 ↗
Decision Date April 10, 2000
Product Code DTB
Device Class Class 3
Evidence 0 studies
The Stela pacing leads were cleared through the FDA 510(k) pathway on April 10, 2000. Manufactured by Ela Medical, these devices are classified as Class III under product code DTB.
What It Is
The Stela UT46/BT45 and UJ45/BJ44 are implantable pacing leads designed for use with pacemakers. These leads are available in both straight and J-shaped configurations, featuring tines that help secure the lead in the heart tissue. They transmit electrical impulses from the pacemaker to the heart muscle, ensuring proper heart rhythm management.
Clinical Applications
These pacing leads are commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or other rhythm disorders. Cardiologists and electrophysiologists typically perform these procedures in hospital settings. The leads are suitable for a wide range of patients, including those with heart block or atrial fibrillation requiring rate control.
Indications for Use
The Stela pacing leads are indicated for patients who require cardiac pacing due to conditions like bradycardia or heart block. They are used to maintain adequate heart rates in patients whose natural pacemaker is not functioning properly.
Practical Considerations
The Stela leads come in various lengths to accommodate different patient anatomies and are compatible with a range of pacemaker devices. Clinicians should be familiar with the specific implantation techniques and ensure proper lead positioning to optimize device performance.
Frequently Asked Questions
What is Stela UT46/BT45 & UJ45/BJ44 used for?
These pacing leads are used in cardiac pacing procedures to manage heart rhythm disorders.
What specialties typically use this device?
Cardiologists and electrophysiologists use these leads during pacemaker implantation procedures.
What are the FDA-cleared indications?
The leads 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.