📊 Evidence-Based Reference
Medtronic Permanent Lead Introducer
Medtronic Vascular
Summary: The Medtronic Permanent Lead Introducer is a device used in cardiac procedures, primarily for lead placement. It is FDA-cleared and linked to studies on cardiac resynchronization and leadless pacemakers.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K874167 ↗
Decision Date ?
December 7, 1987
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Medtronic Permanent Lead Introducer was cleared through the FDA 510k pathway on December 7, 1987. It is manufactured by Medtronic Vascular and classified as a Class 3 device.
What It Is
The Medtronic Permanent Lead Introducer is a medical device designed to facilitate the placement of permanent leads in cardiac procedures. It is intended for use in procedures requiring precise lead positioning.
FDA-Cleared Indications
- Used to facilitate the introduction and placement of permanent cardiac leads.
- Used during procedures that require positioning a permanent lead within the heart.
Clinical Applications
- Introducing a permanent pacing lead during pacemaker implantation.
- Facilitating placement of a permanent lead when controlled positioning is needed.
- Supporting lead placement during selected cardiac electrophysiology procedures.
Evidence Summary
The available literature includes two studies from 2021, focusing on cardiac resynchronization through His bundle pacing and strategies for leadless pacemaker implantation. These studies provide insights into device efficacy and safety.
Reported Outcomes
Published studies report improvements in left ventricular ejection fraction and intraventricular synchrony with His bundle pacing. Additionally, leadless pacemakers have been shown to reduce complications associated with traditional pacemakers.
Safety Profile
Reported complications include issues related to lead placement and device implantation. However, the studies highlight the potential for reduced complications with leadless pacemakers compared to traditional systems.
Evidence Limitations
The evidence is limited by the small number of studies and the focus on specific pacing techniques. Further research is needed to explore long-term outcomes and broader clinical applications.
Practical Considerations
- The introducer must be matched to the lead, guidewire, and other components used in the procedure.
- The access route and size depend on the target cardiac chamber, venous anatomy, and the lead system being implanted.
- Use requires fluoroscopic or other appropriate imaging guidance and sterile technique.
- MRI safety depends on the complete implanted lead system and pacemaker or other cardiac device, not the introducer alone.
- Contraindications, warnings, and handling requirements should be taken from the current manufacturer labeling; the 1987 FDA record may not contain current product specifications.
Frequently Asked Questions
What are the clinical indications for Medtronic Permanent Lead Introducer?
The device is indicated for use in cardiac procedures requiring permanent lead placement, such as cardiac resynchronization therapy.
What outcomes have been reported in clinical studies?
Studies have reported improvements in cardiac function, specifically left ventricular ejection fraction, with the use of His bundle pacing.
What complications have been reported?
Safety data indicate potential complications related to lead placement, but leadless pacemakers may reduce these risks compared to traditional systems.
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.