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transvenous tined ventricular atrial
Medtronic Vascular
Summary: The transvenous tined ventricular atrial device by Medtronic Vascular is used for cardiac pacing. It is FDA 510k cleared. Key evidence highlights its use in pediatric and adult populations with congenital heart disease and bradyarrhythmias.
FDA Clearance Information
Pathway
510K
Number
K842031 ↗
Decision Date
January 18, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared by the FDA through the 510k pathway on January 18, 1985. It is manufactured by Medtronic Vascular and classified as a Class 3 device.
What It Is
The transvenous tined ventricular atrial device is a cardiac pacing device designed to maintain heart rhythm. It is used in patients requiring ventricular and atrial pacing, particularly in cases of bradyarrhythmias and congenital heart disease.
Clinical Applications
This device is commonly used in patients with bradyarrhythmias, including children and young adults with congenital heart disease. It is also applicable in scenarios requiring permanent pacemaker implantation, such as persistent left superior vena cava cases.
Evidence Summary
The literature includes 10 studies, ranging from 1984 to 2012, covering various study types such as RCTs, prospective, and retrospective studies. These studies focus on the device's application in both human and veterinary medicine.
Reported Outcomes
Published studies report successful long-term outcomes in pediatric patients with congenital heart disease and in dogs with cardiac conditions. Survival rates and lead stability are highlighted, with one study noting a mean survival time of 16.9 months in dogs.
Safety Profile
Reported complications include lead dislodgement, with occurrences noted in both tined and untined leads, as well as infection and hematoma formation. These complications were observed in both human and veterinary applications.
Evidence Limitations
The evidence is limited by the small sample sizes and the focus on specific populations, such as pediatric patients and veterinary subjects. Further research is needed to assess long-term outcomes in broader patient populations.
Frequently Asked Questions
What are the clinical indications for transvenous tined ventricular atrial device?
The device is indicated for use in patients with bradyarrhythmias and congenital heart disease requiring ventricular and atrial pacing.
What outcomes have been reported in clinical studies?
Studies report successful long-term outcomes in pediatric and veterinary populations, with notable survival rates and lead stability.
What complications have been reported?
Safety data indicate complications such as lead dislodgement, infection, and hematoma formation.
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.