đź“Š Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Myocardial pacing when transvenous lead placement is not feasible.
- Direct attachment of a cardiac pacing lead to the myocardium during surgical or alternative pacemaker implantation.
Clinical Applications
- Myocardial pacing when venous access or cardiac venous anatomy prevents conventional transvenous lead placement.
- Placement of a pacing lead directly on or into the heart muscle during epicardial or other surgical pacing procedures.
- Cardiac pacing when a transvenous approach presents technical difficulties or an unacceptable risk of lead instability.
Reported off-label uses
- Use as part of selected cardiac resynchronization strategies when a coronary sinus or other transvenous lead cannot be positioned.
- Use in selected patients with complex congenital heart disease or prior cardiac surgery when standard lead routes are unavailable.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The lead must be compatible with the selected pacemaker generator and its connector system; compatibility should be confirmed before implantation.
- The implantation technique, lead length, fixation method, and available configurations depend on the specific model and surgical approach.
- MRI safety is model-specific. Do not assume the lead is MRI-conditional; review the exact labeling and the complete pacemaker system before MRI.
- Potential concerns include inadequate electrical sensing or capture, lead dislodgement, fracture, infection, bleeding, and myocardial injury.
- This device is intended for use by clinicians experienced in cardiac pacing and should not be used when the patient’s anatomy or clinical condition prevents secure myocardial fixation.
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.