📊 Evidence-Based Reference
Medtronic Permanent Lead Introducer Various Mdls
Medtronic Vascular
Summary: The Medtronic Permanent Lead Introducer is a device used for lead placement in cardiac procedures. It is primarily used in cardiac resynchronization and pacing. Key evidence highlights its role in improving left ventricular ejection fraction and safe implantation strategies.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K911236 ↗
Decision Date ?
June 18, 1991
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 June 18, 1991. 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. It is used in the context of cardiac resynchronization therapy and pacing, providing a pathway for lead insertion.
FDA-Cleared Indications
- Facilitation of the placement of permanent cardiac pacing leads.
- Use during cardiac procedures in which a lead introducer is needed to access the intended cardiac lead position.
Clinical Applications
- Placement of permanent pacemaker leads.
- Placement of leads used for cardiac resynchronization therapy.
- Establishing access for cardiac lead insertion under fluoroscopic or other appropriate imaging guidance.
Evidence Summary
The available literature includes two studies from 2021, focusing on cardiac resynchronization and leadless pacemaker implantation. The studies vary in design, including randomized controlled trials and case series.
Reported Outcomes
Published studies report that the use of the Medtronic Permanent Lead Introducer in cardiac resynchronization therapy can lead to early improvements in left ventricular ejection fraction. Additionally, strategies for safe implantation of leadless pacemakers have been documented, highlighting its utility in unconventional clinical scenarios.
Safety Profile
Reported complications include those typically associated with lead placement and pacing procedures, although specific adverse events are not detailed in the provided studies. The safety profile is generally favorable, with emphasis on minimizing lead- and pocket-associated complications.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed safety outcomes. Further research is needed to explore long-term efficacy and safety, as well as to expand on the clinical scenarios where this device is most beneficial.
Practical Considerations
- The record covers various models, so the available introducer size, length, configuration and compatibility must be confirmed in the specific model labeling.
- The device should be used with compatible cardiac leads and accessories according to the manufacturer's instructions.
- Insertion is generally performed through venous access, commonly involving the cephalic, axillary or subclavian vein, with imaging guidance.
- The FDA record alone does not establish MRI safety. MRI conditions must be checked for the complete implanted system, including the lead, generator and any retained components.
- Potential access-related complications include bleeding, hematoma, infection, venous injury, pneumothorax and lead-placement complications.
Frequently Asked Questions
What are the clinical indications for Medtronic Permanent Lead Introducer?
The device is indicated for use in cardiac resynchronization therapy and pacing procedures, particularly in patients with heart failure and conduction disorders.
What outcomes have been reported in clinical studies?
Studies have reported improvements in left ventricular ejection fraction and safe implantation strategies for leadless pacemakers.
What complications have been reported?
Reported complications include general risks associated with lead placement, but specific adverse events are not detailed in the provided 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.