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leads implantable cardiac pacemakers
Oscor
Summary: Leads implantable cardiac pacemakers by Oscor are devices used to manage brady-arrhythmias. Cleared by FDA via 510k pathway, they are supported by 15 studies highlighting their efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K782018 ↗
Decision Date
June 4, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The leads implantable cardiac pacemakers by Oscor were cleared by the FDA through the 510k pathway on June 4, 1979. They are classified as Class 3 medical devices.
What It Is
Leads implantable cardiac pacemakers are devices designed to regulate heart rhythm by delivering electrical impulses to the heart. They are primarily used in patients with brady-arrhythmias to maintain an adequate heart rate.
Clinical Applications
These pacemakers are commonly used in clinical scenarios involving symptomatic bradycardia, heart block, or other conditions where heart rate regulation is necessary. They provide a reliable solution for patients requiring long-term pacing support.
Evidence Summary
The available literature includes 15 studies, encompassing various study types such as RCTs, prospective, and retrospective analyses. The studies span from 2021 to 2024, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that leads implantable cardiac pacemakers effectively manage brady-arrhythmias with a significant reduction in symptoms. The evidence suggests improved patient outcomes in terms of heart rate stabilization and quality of life. Long-term follow-up indicates sustained efficacy in maintaining cardiac rhythm.
Safety Profile
Reported complications include a 15% complication rate at three years, primarily associated with traditional transvenous pacemakers. The studies highlight risks such as infection and lead-related issues, emphasizing the need for careful patient monitoring.
Evidence Limitations
The evidence is limited by the relatively small sample sizes and the focus on traditional pacemakers. Further research is needed to explore long-term outcomes and compare newer leadless technologies with traditional devices.
Frequently Asked Questions
What are the clinical indications for leads implantable cardiac pacemakers?
Leads implantable cardiac pacemakers are indicated for patients with brady-arrhythmias, heart block, and other conditions requiring heart rate regulation.
What outcomes have been reported in clinical studies?
Studies report effective management of brady-arrhythmias, improved heart rate stabilization, and enhanced quality of life for patients.
What complications have been reported?
Reported complications include a 15% complication rate at three years, with risks such as infection and lead-related issues.
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.