đź“Š Evidence-Based Reference
lead sutureless myocardial
Daig
Summary: The lead sutureless myocardial device by Daig is used for cardiac pacing without the need for sutures. It is primarily used in scenarios where traditional lead placement is challenging. Key evidence highlights its effectiveness and safety in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K782087 ↗
Decision Date
January 15, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The lead sutureless myocardial device was cleared by the FDA via the 510(k) pathway on January 15, 1979. It is manufactured by Daig and classified as a Class 3 device.
What It Is
The lead sutureless myocardial is a cardiac pacing device designed to be implanted without sutures. It is intended for use in patients requiring myocardial pacing, particularly in cases where traditional suture-based leads are not feasible.
Clinical Applications
This device is commonly used in cardiac resynchronization therapy, especially in patients with anatomical challenges or complications with traditional lead placement. It provides an alternative for patients with congestive heart failure requiring pacing.
Evidence Summary
The available literature includes 10 studies, ranging from 1983 to 2022, encompassing various study types such as RCTs and case series. These studies evaluate the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the lead sutureless myocardial device is effective in maintaining pacing thresholds and ensuring reliable cardiac pacing. Clinical evaluations indicate that the device performs comparably to traditional leads, with minimal changes in pacing thresholds over time.
Safety Profile
Reported complications include lead failure due to exit block or loss of contact with the myocardium. However, the overall safety profile is favorable, with no significant adverse events directly attributed to the device in the studies reviewed.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term follow-up in some studies. Further research is needed to evaluate the device's performance in diverse patient populations and over extended periods.
Frequently Asked Questions
What are the clinical indications for lead sutureless myocardial?
The device is indicated for patients requiring myocardial pacing, particularly when traditional suture-based lead placement is not feasible.
What outcomes have been reported in clinical studies?
Studies report effective pacing with stable thresholds and reliable performance comparable to traditional leads.
What complications have been reported?
Safety data indicate potential complications such as lead failure due to exit block or loss of myocardial contact, but overall safety is favorable.
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.