đź“Š Evidence-Based Reference
ventricular leads
Medtronic Vascular
Summary: Ventricular leads by Medtronic Vascular are used in cardiac resynchronization therapy (CRT) and other cardiac interventions. Key evidence highlights the performance differences between epicardial and transvenous leads, as well as bipolar versus quadripolar designs.
FDA Clearance Information
Pathway
510K
Number
K772203 ↗
Decision Date
January 11, 1978
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The ventricular leads by Medtronic Vascular were cleared via the FDA 510(k) pathway on January 11, 1978. They are classified as Class III devices.
What It Is
Ventricular leads are medical devices used in cardiac resynchronization therapy and other cardiac interventions to deliver electrical impulses to the heart. They are designed to improve cardiac function in patients with heart failure or arrhythmias.
Clinical Applications
Ventricular leads are commonly used in patients undergoing cardiac resynchronization therapy, particularly those with heart failure and reduced ejection fraction. They are also used in patients with pacemakers or implantable cardioverter-defibrillators.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series. The studies range from 2021 to 2025, focusing on the performance and outcomes of different ventricular lead designs.
Reported Outcomes
Published studies report that quadripolar left ventricular leads offer advantages over bipolar leads, including reduced risk of lead instability and phrenic nerve stimulation. Epicardial leads, placed via video-assisted thoracic surgery, are used when transvenous placement is unsuccessful.
Safety Profile
Reported complications include lead instability, high pacing thresholds, and phrenic nerve stimulation, which may require lead revision or replacement. The risk of lead damage during transcatheter tricuspid valve interventions is also noted.
Evidence Limitations
There is limited long-term data on the performance of newer quadripolar lead designs. Further research is needed to assess the long-term safety and efficacy of different lead types in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for ventricular leads?
Ventricular leads are indicated for use in cardiac resynchronization therapy and in patients with pacemakers or implantable cardioverter-defibrillators.
What outcomes have been reported in clinical studies?
Studies report that quadripolar leads reduce the risk of lead instability and phrenic nerve stimulation compared to bipolar leads.
What complications have been reported?
Safety data indicate complications such as lead instability, high pacing thresholds, and phrenic nerve stimulation.
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.