đź“Š Evidence-Based Reference
Medtronic Implantable Pacing Leads W Is-1 Conn
Medtronic Vascular
Summary: Medtronic implantable pacing leads are used in cardiac pacing systems. They are primarily used to maintain adequate heart rate in patients with bradycardia. Key evidence highlights challenges with lead failures and device-related complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K896313 ↗
Decision Date ?
March 6, 1990
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Medtronic implantable pacing leads were cleared via the FDA 510(k) pathway on March 6, 1990. Manufactured by Medtronic Vascular, these devices are classified as Class III under product code DTB.
What It Is
The Medtronic implantable pacing leads are components of cardiac pacing systems designed to deliver electrical impulses to the heart muscle to maintain an adequate heart rate. They are intended for use in patients with bradycardia or other conditions requiring cardiac pacing.
FDA-Cleared Indications
- Use as part of an implantable cardiac pacing system when electrical stimulation of the heart is indicated.
- Use in patients requiring pacing support for bradycardia or cardiac conduction disorders.
- Use with compatible cardiac pulse generators through an IS-1 connector.
Clinical Applications
- Permanent pacemaker implantation for symptomatic bradycardia.
- Pacing support for atrioventricular block and other conduction disorders.
- Connection of a transvenous pacing lead to a compatible cardiac pulse generator.
- Delivery of electrical stimulation to the appropriate heart chamber as part of an implanted pacing system.
Reported off-label uses
- Use in selected congenital or inherited conduction disorders requiring long-term pacing.
- Use in some patients after cardiac surgery or ablation when persistent pacing support is needed.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes 14 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series. The studies span from recent years, with a focus on device efficacy and safety.
Reported Outcomes
Published studies report that while the pacing leads effectively maintain heart rhythm, lead failures can occur, leading to inappropriate therapies and ineffective pacing. The PRAETORIAN trial highlighted noninferiority of subcutaneous ICDs compared to transvenous ICDs in terms of device-related complications.
Safety Profile
Reported complications include lead failures, which can result in inappropriate therapies and life-threatening outcomes. Device-device interference, particularly with abandoned pacemakers, has also been documented.
Evidence Limitations
Current evidence is limited by the variability in study designs and the relatively small sample sizes in some studies. Further research is needed to explore long-term outcomes and the impact of technological advancements on lead performance.
Practical Considerations
- The lead must be matched to a compatible generator and connector configuration; the IS-1 connector standard does not by itself establish compatibility with every generator.
- Lead length, diameter, fixation method, insulation, and electrode configuration vary by model and must be confirmed in the specific product labeling.
- Placement is usually performed through venous access with fluoroscopic guidance, followed by testing of sensing, pacing thresholds, and lead impedance.
- MRI eligibility depends on the exact lead model, generator, complete implanted system, and institutional MRI conditions. A lead should not be considered MRI-safe based only on the manufacturer name or IS-1 connector.
- Potential complications include lead dislodgment, fracture, insulation failure, loss of capture or sensing, infection, venous thrombosis, perforation, and complications related to venous access.
Frequently Asked Questions
What are the clinical indications for Medtronic implantable pacing leads?
The leads are indicated for use in patients requiring cardiac pacing, such as those with bradycardia or heart block.
What outcomes have been reported in clinical studies?
Studies report effective pacing but highlight issues with lead failures and device-related complications.
What complications have been reported?
Safety data indicate complications such as lead failures and device-device interference.
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.