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implantable endocardial pacing leads
Oscor
Summary: Implantable endocardial pacing leads by Oscor are used for cardiac pacing. Cleared by FDA via 510k pathway. Key evidence highlights lead integrity concerns in specific pacing techniques.
FDA Clearance Information
Pathway
510K
Number
K831997 ↗
Decision Date
October 20, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The implantable endocardial pacing leads by Oscor were cleared by the FDA through the 510k pathway on October 20, 1983. They are classified as Class 3 medical devices.
What It Is
Implantable endocardial pacing leads are devices used to deliver electrical impulses to the heart to maintain an adequate heart rate. They are primarily used in patients with bradycardia or heart block.
Clinical Applications
These leads are commonly used in scenarios requiring cardiac resynchronization therapy or in patients with heart failure and conduction system diseases. They are also utilized in cases where traditional pacing methods are not feasible.
Evidence Summary
The available literature includes 14 studies, comprising RCTs, prospective, and retrospective analyses, published between 2017 and 2025. These studies evaluate lead integrity, pacing techniques, and clinical outcomes.
Reported Outcomes
Published studies report that implantable endocardial pacing leads are effective in improving cardiac resynchronization therapy outcomes. They enhance left ventricular function and reduce heart failure symptoms. However, concerns about lead integrity in specific pacing techniques like left bundle branch area pacing have been noted.
Safety Profile
Reported complications include issues with lead integrity, particularly in left bundle branch area pacing. Other studies highlight potential complications related to venous access and infections.
Evidence Limitations
The evidence is limited by the relatively small number of studies focusing on specific pacing techniques. Further research is needed to fully understand long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for implantable endocardial pacing leads?
They are indicated for patients requiring cardiac pacing due to bradycardia, heart block, or heart failure requiring resynchronization therapy.
What outcomes have been reported in clinical studies?
Studies report improved cardiac resynchronization therapy outcomes, enhanced left ventricular function, and reduced heart failure symptoms.
What complications have been reported?
Safety data indicate complications such as lead integrity issues and potential problems with venous access and infections.
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.