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lead timed pacing implantable
Daig
Summary: The lead timed pacing implantable by Daig is a device used for cardiac pacing, primarily in cases of ventricular tachycardia. Key evidence suggests efficacy in left bundle branch area pacing compared to right ventricular pacing.
FDA Clearance Information
Pathway
510K
Number
K782004 ↗
Decision Date
December 15, 1978
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared by the FDA through the 510k pathway on December 15, 1978. It is manufactured by Daig and classified as a Class 3 device.
What It Is
The lead timed pacing implantable is a medical device designed to deliver timed electrical pulses to the heart, aiding in the management of arrhythmias such as ventricular tachycardia. It is intended for use in patients requiring precise cardiac pacing.
Clinical Applications
Commonly used in patients with arrhythmias, particularly ventricular tachycardia, the device is often employed in scenarios where synchronized cardiac pacing is critical. It is also used in cardiac resynchronization therapy.
Evidence Summary
The literature includes 10 studies, comprising randomized controlled trials and case series, published between 2020 and 2025. These studies explore various pacing configurations and their effects on cardiac function.
Reported Outcomes
Published studies report that antitachycardia pacing delivered to the left bundle branch area is more effective than right ventricular pacing in terminating ventricular tachycardia. Additionally, cardiac resynchronization therapy has shown efficacy in patients with narrow QRS duration.
Safety Profile
Reported complications include the need for multiple pacing electrodes in cardiac contractility modulation therapy and potential issues with synchronization in certain pacing configurations.
Evidence Limitations
Current evidence is limited by the small sample sizes and the need for further research on long-term outcomes and safety. More comprehensive studies are required to validate findings across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for lead timed pacing implantable?
The device is indicated for patients with arrhythmias such as ventricular tachycardia, where precise cardiac pacing is necessary.
What outcomes have been reported in clinical studies?
Studies have reported improved efficacy in left bundle branch area pacing for terminating ventricular tachycardia and effective cardiac resynchronization in patients with narrow QRS duration.
What complications have been reported?
Safety data indicate potential complications such as the requirement for multiple pacing electrodes and synchronization issues in certain configurations.
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.