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products implantable pacing lead tined
Oscor
Summary: The implantable pacing lead tined by Oscor is used for cardiac pacing. It has FDA 510k clearance and is supported by two studies, highlighting its use in high-impedance pacing and atrial lead implantation.
FDA Clearance Information
Pathway
510K
Number
K823446 ↗
Decision Date
December 3, 1982
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The implantable pacing lead tined by Oscor was cleared via the FDA 510k pathway on December 3, 1982. It is classified as a Class 3 device.
What It Is
The implantable pacing lead tined is a medical device used for cardiac pacing. It is designed to deliver electrical impulses to the heart to maintain an adequate heart rate, especially in patients with bradycardia.
Clinical Applications
This device is commonly used in scenarios requiring cardiac pacing, such as in patients with heart block or sinus node dysfunction. It is particularly useful in maintaining heart rhythm and preventing complications associated with slow heart rates.
Evidence Summary
The available literature includes two studies: one from 1999 and another from 2004. These studies encompass various designs, including prospective and retrospective analyses, focusing on the device's performance and safety.
Reported Outcomes
Published studies report that the implantable pacing lead tined has favorable implantation data with low pacing thresholds. The 1999 study noted better pacing thresholds compared to other atrial leads, indicating effective performance.
Safety Profile
Reported complications include acute lead-related issues such as dislodgment and diaphragmatic pacing, which occasionally required reoperation or abandonment. These findings highlight the importance of careful monitoring post-implantation.
Evidence Limitations
The evidence is limited by the small number of studies and lack of comprehensive safety data. Further research is needed to establish long-term outcomes and safety profiles, as well as to explore the device's performance in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for implantable pacing lead tined?
The device is indicated for cardiac pacing in patients with conditions such as heart block or sinus node dysfunction.
What outcomes have been reported in clinical studies?
Studies have reported favorable pacing thresholds and effective performance compared to other atrial leads.
What complications have been reported?
Safety data indicate complications such as lead dislodgment and diaphragmatic pacing, sometimes requiring reoperation.
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.