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porous tip endocardial lead
Daig
Summary: The porous tip endocardial lead by Daig is used for permanent atrial or ventricular pacing. Key evidence highlights its low chronic stimulation thresholds and stability over time.
FDA Clearance Information
Pathway
510K
Number
K830743 ↗
Decision Date
May 9, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The porous tip endocardial lead was cleared by the FDA via the 510k pathway on May 9, 1983. It is manufactured by Daig and classified as a Class 3 device.
What It Is
The porous tip endocardial lead is a cardiac pacing device designed to be implanted in the heart for permanent atrial or ventricular pacing. It features a porous tip mesh electrode that enhances pacing and sensing thresholds, with a screw-in mechanism for secure endocardial fixation.
Clinical Applications
This device is commonly used in patients requiring permanent cardiac pacing, particularly in scenarios where stable long-term pacing thresholds are critical. It is suitable for both atrial and ventricular applications.
Evidence Summary
The literature includes five studies, primarily from the 1980s, involving various study designs. These studies collectively report on the device's performance in terms of pacing thresholds and safety.
Reported Outcomes
Published studies report that the porous tip endocardial lead achieves low chronic stimulation thresholds and maintains threshold stability over time. One study noted a mean pulse width threshold of 0.0534 ms 24 hours post-implantation, with minimal variation over six months.
Safety Profile
Reported complications include a low incidence of electrode repositioning due to exit block. Overall, the device demonstrates a favorable safety profile with no significant adverse events reported in the studies.
Evidence Limitations
The evidence is limited by the age of the studies, with most data originating from the 1980s. There is a need for more recent research to validate these findings in contemporary clinical settings.
Frequently Asked Questions
What are the clinical indications for porous tip endocardial lead?
The device is indicated for permanent atrial or ventricular pacing, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
Studies report low chronic stimulation thresholds and stable long-term pacing performance.
What complications have been reported?
Safety data indicate a low rate of complications, with occasional need for electrode repositioning due to exit block.
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.