đź“Š Evidence-Based Reference
Endocardial Bipolar Lead
American Technology
Summary: The endocardial bipolar lead by American Technology is a cardiac device used for pacing and sensing in the heart. Key evidence highlights its use in cardiac resynchronization therapy and pediatric pacing.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K781456 ↗
Decision Date ?
December 4, 1978
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The endocardial bipolar lead was cleared by the FDA through the 510(k) pathway on December 4, 1978. It is manufactured by American Technology and classified as a Class III device.
What It Is
The endocardial bipolar lead is a cardiac device designed for implantation within the heart to provide electrical pacing and sensing. It is used in conjunction with pacemakers or defibrillators to manage arrhythmias.
FDA-Cleared Indications
- Pacing and sensing within the heart when connected to a compatible cardiac pulse generator.
- Use in patients who require endocardial cardiac pacing for management of an indicated bradyarrhythmia or conduction disorder.
Clinical Applications
- Endocardial pacing for selected patients with symptomatic slow heart rhythms or conduction abnormalities.
- Sensing cardiac electrical activity for pacemaker or defibrillator system function.
- Use as part of a cardiac resynchronization system when the lead configuration and labeling support that application.
- Pacing in pediatric patients when the lead size, anatomy, and product labeling are appropriate.
Evidence Summary
The literature includes 15 studies ranging from 2014 to 2022, comprising randomized controlled trials, prospective and retrospective studies, and case series. These studies explore various clinical applications and outcomes.
Reported Outcomes
Published studies report that the endocardial bipolar lead is effective in cardiac resynchronization therapy, improving morbidity and mortality in heart failure patients. In pediatric patients, it shows long-term performance benefits, especially in those with congenital heart disease.
Safety Profile
Reported complications include challenges in long-term performance in pediatric patients and potential issues with lead fixation. However, specific adverse events are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks large-scale randomized controlled trials specifically focusing on the endocardial bipolar lead. Further research is needed to explore long-term safety and efficacy in diverse patient populations.
Practical Considerations
- The lead must be matched to the pulse generator, connector standard, pacing mode, and electrical specifications of the cardiac device system.
- Lead length, diameter, fixation design, and electrode configuration must be selected for the patient’s cardiac anatomy and implantation route.
- Implantation typically requires venous access and fluoroscopic guidance, followed by positioning in an appropriate heart chamber and electrical testing.
- MRI safety depends on the specific lead, pulse generator, and complete implanted system; older or non-MRI-conditional systems may require MRI avoidance or specialized assessment.
- Potential complications include infection, bleeding, lead dislodgement, venous thrombosis, cardiac perforation, arrhythmia, and loss of pacing or sensing.
Frequently Asked Questions
What are the clinical indications for endocardial bipolar lead?
The device is indicated for use in cardiac resynchronization therapy and pacing in patients with heart failure and electrical dyssynchrony, as well as in pediatric patients with congenital heart disease.
What outcomes have been reported in clinical studies?
Studies have shown improved morbidity and mortality in heart failure patients and long-term performance benefits in pediatric patients.
What complications have been reported?
Reported complications include challenges with long-term performance and lead fixation, particularly in pediatric patients.
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.