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unipoplar endocardial leads
American Technology
Summary: Unipolar endocardial leads are used in cardiac pacing. They are primarily used for patients requiring cardiac resynchronization therapy. Key evidence highlights their role in improving heart function.
FDA Clearance Information
Pathway
510K
Number
K781326 ↗
Decision Date
December 4, 1978
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The unipolar endocardial leads by American Technology were cleared by the FDA via the 510k pathway on December 4, 1978. They are classified as Class 3 medical devices.
What It Is
Unipolar endocardial leads are devices used in cardiac pacing, specifically for cardiac resynchronization therapy. They function by delivering electrical impulses to the heart muscle to maintain a regular heartbeat.
Clinical Applications
These leads are commonly used in patients with heart failure requiring cardiac resynchronization therapy. They are also considered in cases where traditional lead placement is challenging due to venous access issues.
Evidence Summary
The literature includes 10 studies, encompassing various study types such as RCTs and case series, with publication dates ranging from 2017 to 2025.
Reported Outcomes
Published studies report that unipolar endocardial leads are effective in improving cardiac function in patients undergoing cardiac resynchronization therapy. They have been shown to be beneficial in cases with venous access challenges and in reducing symptoms of heart failure.
Safety Profile
Reported complications include potential issues with lead placement and infections. However, the studies provided do not detail specific adverse events related to the use of unipolar endocardial leads.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials specifically focusing on unipolar endocardial leads. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for unipolar endocardial leads?
Unipolar endocardial leads are indicated for patients requiring cardiac resynchronization therapy, particularly those with heart failure and venous access challenges.
What outcomes have been reported in clinical studies?
Studies report improved cardiac function and symptom relief in heart failure patients using unipolar endocardial leads.
What complications have been reported?
Safety data from studies indicate potential complications such as lead placement issues and infections, though specific adverse events are not detailed in the provided evidence.
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.