đź“Š Evidence-Based Reference
Medtronic A-V Pacing System Analyzer
Medtronic Vascular
Summary: The Medtronic A-V Pacing System Analyzer is a device used to assess pacing system functionality. It is primarily used in cardiac pacing procedures. Current evidence includes studies on lead fixation and long-term pacing efficacy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K812262 ↗
Decision Date ?
June 17, 1982
Product Code ?
DTC
Device Class ?
Class 2
Evidence ?
0 studies
The Medtronic A-V Pacing System Analyzer was cleared by the FDA via the 510k pathway on June 17, 1982. It is manufactured by Medtronic Vascular and is classified as a Class 2 device.
What It Is
The Medtronic A-V Pacing System Analyzer is designed to evaluate the performance of cardiac pacing systems. It is used to ensure proper lead placement and pacing efficacy in patients requiring cardiac rhythm management.
FDA-Cleared Indications
- Assessment of cardiac pacing system function.
- Testing of pacemaker lead performance during cardiac pacing procedures.
- Evaluation of atrioventricular pacing-system function.
Clinical Applications
- Intraoperative testing of pacemaker lead function.
- Assessment of pacing thresholds and sensing during pacemaker implantation.
- Evaluation of atrial and ventricular pacing-system performance.
- Confirmation of appropriate lead placement and electrical connection.
Evidence Summary
The available literature includes two studies registered on ClinicalTrials.gov. These studies focus on lead fixation and long-term pacing efficacy. The total number of participants and specific study dates are not provided.
Reported Outcomes
Published studies report on the potential of slew rate as a predictor for optimal lead fixation and the long-term efficacy of left bundle branch pacing. However, specific outcomes and efficacy rates are not detailed in the provided evidence.
Safety Profile
Reported complications include potential issues related to lead fixation and long-term pacing stability. Specific adverse events are not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the lack of detailed outcomes and safety data. Further research is needed to establish comprehensive efficacy and safety profiles, as well as to explore additional clinical applications.
Practical Considerations
- This is an external pacing-system analyzer, not an implanted pacemaker or lead.
- It is used with compatible pacing leads, connectors, cables, and testing equipment; compatibility should be confirmed before use.
- Testing is typically performed under continuous electrocardiographic and hemodynamic monitoring by trained cardiac electrophysiology or pacing personnel.
- The analyzer itself is not an MRI implant. MRI safety depends on the implanted pacemaker system and its specific labeling; an external analyzer should not be brought into the MRI environment unless expressly permitted by the manufacturer.
- Use should follow the device manual and institutional protocols, including electrical-safety precautions and patient-specific assessment.
Frequently Asked Questions
What are the clinical indications for Medtronic A-V Pacing System Analyzer?
The device is indicated for use in assessing and optimizing cardiac pacing systems, particularly in atrioventricular pacing procedures.
What outcomes have been reported in clinical studies?
Studies have explored the role of slew rate in lead fixation and the efficacy of left bundle branch pacing, though specific outcomes are not detailed.
What complications have been reported?
Reported complications include potential issues with lead fixation and pacing stability, but specific adverse events are not detailed in the studies.
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.