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lead sutureless myocardial
Daig
Summary: The lead sutureless myocardial device by Daig is used for cardiac pacing without sutures. It is primarily used in cases where transvenous placement is not feasible. Key evidence highlights its effectiveness and safety in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K800355 ↗
Decision Date
May 28, 1980
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 May 28, 1980. It is manufactured by Daig and classified as a Class 3 device.
What It Is
The lead sutureless myocardial device is designed for myocardial pacing without the need for sutures. It is used in cardiac resynchronization therapy, especially when transvenous lead placement is challenging due to anatomical or technical issues.
Clinical Applications
This device is commonly used in patients requiring cardiac pacing where traditional transvenous lead placement is not possible, such as in cases of coronary sinus abnormalities or when there is a risk of lead dislodgement.
Evidence Summary
The literature includes 10 studies, ranging from 1983 to 2013, encompassing RCTs, prospective, and retrospective studies. 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. The device has shown comparable performance to traditional transvenous leads in terms of pacing thresholds and lead stability.
Safety Profile
Reported complications include lead failure due to exit block or loss of contact with the myocardium. No instances of electrode fracture or insulation loss were observed in the studies reviewed.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term follow-up data in some studies. Further research is needed to assess the long-term durability and performance of the device in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for lead sutureless myocardial?
The device is indicated for use in cardiac pacing, particularly when transvenous lead placement is not feasible due to anatomical or technical challenges.
What outcomes have been reported in clinical studies?
Studies report effective pacing thresholds and reliable performance, comparable to traditional transvenous leads.
What complications have been reported?
Safety data indicate complications such as lead failure due to exit block or loss of myocardial contact, but no electrode fractures or insulation issues were noted.
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.