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permanent pacing lead
Oscor Medical
Summary: The permanent pacing lead by Oscor Medical is used in cardiac pacing for patients with arrhythmias. Key evidence highlights include cases of lead migration and associated complications.
FDA Clearance Information
Pathway
510K
Number
K905300 ↗
Decision Date
May 7, 1991
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The permanent pacing lead by Oscor Medical was cleared via the FDA 510k pathway on May 7, 1991. It is classified as a Class 3 device under product code DTB.
What It Is
The permanent pacing lead is a device used in cardiac pacing systems to deliver electrical impulses to the heart. It is intended for patients requiring long-term pacing due to arrhythmias.
Clinical Applications
This device is commonly used in patients with complete atrioventricular block or other bradyarrhythmias requiring permanent pacemaker implantation. It is typically placed transvenously.
Evidence Summary
The literature includes 15 studies, comprising case reports and other observational studies, published between 2022 and 2023. These studies explore complications and outcomes associated with the device.
Reported Outcomes
Published studies report outcomes such as successful pacing and resolution of arrhythmias. However, cases of lead migration and perforation have been documented, requiring surgical intervention.
Safety Profile
Reported complications include cardiac perforation, lead migration, and infection. Surgical removal and repair were necessary in some cases, highlighting the potential risks associated with the device.
Evidence Limitations
The evidence is limited by the small number of case reports and lack of large-scale randomized controlled trials. Further research is needed to better understand long-term outcomes and safety profiles.
Frequently Asked Questions
What are the clinical indications for permanent pacing lead?
The device is indicated for patients with arrhythmias requiring permanent pacing, such as complete atrioventricular block.
What outcomes have been reported in clinical studies?
Studies report successful pacing and arrhythmia resolution, but also document cases of lead migration and perforation.
What complications have been reported?
Safety data indicate complications such as cardiac perforation, lead migration, and infection, sometimes necessitating surgical intervention.
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.