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
510K
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.
Clinical Applications
These pacing leads are commonly used in patients with symptomatic bradycardia, heart block, or other conduction disorders requiring pacing support. They are integral to the function of implantable pacemakers and defibrillators.
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.
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.