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sutureless myocardial pacing lead
Medtronic Vascular
Summary: The sutureless myocardial pacing lead by Medtronic Vascular is a device used for cardiac pacing without the need for sutures. It is primarily used in cases where transvenous lead placement is not feasible. Key evidence suggests its effectiveness in maintaining pacing thresholds.
FDA Clearance Information
Pathway
510K
Number
K780446 ↗
Decision Date
May 19, 1978
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The sutureless myocardial pacing lead was cleared by the FDA via the 510k pathway on May 19, 1978. It is manufactured by Medtronic Vascular and classified as a Class 3 device.
What It Is
The sutureless myocardial pacing lead is designed for cardiac pacing by attaching directly to the myocardium without sutures. It is intended for use in patients requiring cardiac resynchronization therapy, particularly when transvenous lead placement is challenging.
Clinical Applications
This device is commonly used in cardiac resynchronization therapy, especially in patients with anatomical challenges that prevent transvenous lead placement. It provides an alternative for maintaining effective cardiac pacing.
Evidence Summary
The literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series, conducted between 1983 and 2013. These studies evaluate the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report that the sutureless myocardial pacing lead is effective in maintaining pacing thresholds, with some studies indicating threshold superiority of certain screw-in designs. Clinical evaluations suggest the device is reliable for long-term pacing.
Safety Profile
Reported complications include potential phrenic nerve stimulation and lead dislodgement. However, studies indicate that these events are relatively infrequent and can be managed with surgical intervention if necessary.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of recent large-scale randomized controlled trials. Further research is needed to evaluate long-term outcomes and compare the device with newer pacing technologies.
Frequently Asked Questions
What are the clinical indications for sutureless myocardial pacing lead?
The device is indicated for patients requiring cardiac pacing where transvenous lead placement is not feasible due to anatomical challenges.
What outcomes have been reported in clinical studies?
Studies report effective pacing threshold maintenance and reliability in long-term use, with some designs showing threshold superiority.
What complications have been reported?
Reported complications include phrenic nerve stimulation and lead dislodgement, though these are relatively infrequent and manageable.
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.