đź“Š Evidence-Based Reference
Bipolar Pernenous Ventricular Lead
Summary: The bipolar pernenous ventricular lead by Cordis is a cardiac device used primarily in cardiac resynchronization therapy. Key evidence suggests it offers an alternative to quadripolar leads with specific advantages in certain clinical scenarios.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K790344 ↗
Decision Date ?
April 17, 1979
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The bipolar pernenous ventricular lead was cleared by the FDA via the 510(k) pathway on April 17, 1979. It is manufactured by Cordis and classified as a Class III device.
What It Is
The bipolar pernenous ventricular lead is a cardiac device designed for use in cardiac resynchronization therapy. It functions by providing electrical stimulation to the heart's ventricles to improve cardiac function in patients with heart failure.
FDA-Cleared Indications
- Use for ventricular pacing when cardiac stimulation is clinically indicated.
- Use as part of a compatible cardiac pacing system for patients requiring ventricular electrical stimulation.
Clinical Applications
- Ventricular pacing with an implanted pacemaker system.
- Cardiac resynchronization therapy when used with a compatible system and appropriate additional lead configuration.
- Treatment of conduction disorders requiring electrical stimulation of a ventricle.
- Long-term transvenous delivery of pacing impulses to ventricular myocardium.
Reported off-label uses
- Use in selected pacing strategies not specifically described in the original device labeling, based on clinician judgment and contemporary electrophysiology practice.
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 10 studies, comprising randomized controlled trials and case series, published between 2020 and 2024. These studies explore the performance and safety of bipolar versus quadripolar leads.
Reported Outcomes
Published studies report that bipolar leads may offer advantages in terms of lead stability and reduced pacing thresholds compared to quadripolar leads. Some studies suggest better survival outcomes with true bipolar pacing in cardiac resynchronization therapy patients.
Safety Profile
Reported complications include lead instability, high pacing thresholds, and phrenic nerve stimulation. These issues may necessitate lead revision or replacement, although bipolar leads are designed to mitigate some of these challenges.
Evidence Limitations
The evidence is limited by the relatively small number of studies directly comparing bipolar and quadripolar leads. Further research is needed to confirm long-term outcomes and safety in diverse patient populations.
Practical Considerations
- The lead is introduced through the venous system and positioned in a ventricle under fluoroscopic and electrocardiographic guidance.
- It must be matched to a compatible pulse generator, connector configuration, and pacing system; compatibility should be confirmed before implantation.
- Exact lead length, diameter, fixation method, and connector specifications should be verified in the original labeling because these details may vary by model.
- MRI safety depends on the complete implanted system, including the lead, pulse generator, and any extensions. Do not assume the system is MRI safe without confirming its specific labeling.
- Potential complications include infection, bleeding, venous thrombosis, lead dislodgement or fracture, cardiac perforation, arrhythmia, and loss of pacing function.
Frequently Asked Questions
What are the clinical indications for bipolar pernenous ventricular lead?
The device is indicated for use in cardiac resynchronization therapy, particularly in patients with heart failure and conduction abnormalities.
What outcomes have been reported in clinical studies?
Studies have reported improved lead stability and reduced pacing thresholds with bipolar leads, as well as potential survival benefits in certain patient groups.
What complications have been reported?
Safety data indicate potential 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.