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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 ?
510(k)
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.
FDA-Cleared Indications
- Permanent endocardial atrial pacing
- Permanent endocardial ventricular pacing
Clinical Applications
- Atrial lead placement for permanent cardiac pacemaker therapy
- Ventricular lead placement for permanent cardiac pacemaker therapy
- Endocardial fixation using the lead's screw-in mechanism
- Pacing and sensing when stable chronic electrical thresholds are clinically important
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.
Practical Considerations
- The lead is intended for endocardial implantation and requires compatibility with the selected pacemaker generator and pacing system.
- The porous tip and screw-in fixation mechanism require careful handling and positioning to achieve stable electrical contact without damaging the myocardium.
- MRI safety cannot be assumed from the historical FDA record; the lead should be treated as not established as MRI-conditional unless current device-specific labeling confirms otherwise.
- Patient-specific factors, including venous access, cardiac anatomy, infection, bleeding risk and the need for anticoagulation, should be assessed before implantation.
- The historical 1983 510(k) record may not describe current implantation accessories, sizes or compatibility requirements; clinicians should consult the applicable manufacturer labeling.
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.