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Medtronic Permanent Lead Introducer
Medtronic Vascular
Summary: The Medtronic Permanent Lead Introducer is a device used in cardiac procedures. It is primarily utilized for lead placement in cardiac resynchronization therapy. Key evidence suggests its role in improving left ventricular ejection fraction through His bundle pacing.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K854559 ↗
Decision Date ?
December 24, 1985
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Medtronic Permanent Lead Introducer was cleared by the FDA via the 510(k) pathway on December 24, 1985. It is manufactured by Medtronic Vascular and classified as a Class 2 device.
What It Is
The Medtronic Permanent Lead Introducer is designed to facilitate the placement of leads in cardiac procedures, particularly for cardiac resynchronization therapy. It aids in correcting intraventricular conduction disorders through precise lead placement.
FDA-Cleared Indications
- Facilitation of the introduction and placement of permanent cardiac pacing leads.
- Use during procedures requiring placement of a permanent pacemaker or pacing lead.
Clinical Applications
- Introducing a permanent pacing lead through a venous access site.
- Helping position a pacing lead within the heart during pacemaker implantation.
- Supporting lead placement in procedures for cardiac conduction or rhythm disorders when permanent pacing is indicated.
Evidence Summary
The available literature includes two studies published in 2021. These studies explore the efficacy of His bundle pacing and leadless pacemaker strategies, providing insights into the device's clinical applications.
Reported Outcomes
Published studies report that the Medtronic Permanent Lead Introducer is effective in improving left ventricular ejection fraction in heart failure patients through His bundle pacing. Additionally, it is noted for its role in reducing complications associated with traditional pacemaker leads.
Safety Profile
Reported complications include issues related to lead placement and potential procedural challenges. However, the studies emphasize the device's ability to minimize lead- and pocket-associated complications.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of long-term outcome data. Further research is needed to establish comprehensive safety profiles and efficacy across diverse patient populations.
Practical Considerations
- The introducer must be compatible with the selected pacing lead, guidewire, and venous access system; available sizes and configurations depend on the specific catalog number and labeling.
- The device is used under fluoroscopic or other appropriate imaging guidance, usually through venous access such as the cephalic, axillary, or subclavian vein.
- Patients with active infection, severe bleeding risk, venous occlusion, or unsuitable vascular anatomy may require an alternative approach or may not be candidates.
- MRI safety cannot be determined from the generic device name alone. MRI eligibility depends on the exact introducer, implanted lead and pacemaker system, and current manufacturer labeling; the introducer itself is generally removed after the procedure.
- The introducer is a sterile, single-use device and should not be reused or resterilized unless the current FDA-cleared labeling specifically permits it.
Frequently Asked Questions
What are the clinical indications for Medtronic Permanent Lead Introducer?
The device is indicated for use in cardiac resynchronization therapy, particularly in patients with heart failure and intraventricular conduction disorders.
What outcomes have been reported in clinical studies?
Studies have reported improvements in left ventricular ejection fraction and reduced complications associated with traditional pacemaker leads.
What complications have been reported?
Reported complications include procedural challenges and issues related to lead placement, though the device reduces lead- and pocket-associated complications.
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.