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cardiovascular permanent pacemaker electrode
Pacesetter Systems
Summary: The cardiovascular permanent pacemaker electrode by Pacesetter Systems is a device used to manage cardiac arrhythmias. It is primarily used in patients requiring pacing support due to conduction abnormalities. Key evidence highlights its role post-transcatheter aortic valve replacement.
FDA Clearance Information
Pathway
510K
Number
K891905 ↗
Decision Date
June 5, 1989
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The cardiovascular permanent pacemaker electrode was cleared by the FDA through the 510(k) pathway on June 5, 1989. It is manufactured by Pacesetter Systems and classified as a Class III device.
What It Is
The cardiovascular permanent pacemaker electrode is a medical device designed to deliver electrical impulses to the heart to maintain an adequate heart rate in patients with arrhythmias. It is intended for permanent implantation to provide pacing support.
Clinical Applications
This device is commonly used in clinical scenarios involving atrioventricular block, sick sinus syndrome, and post-transcatheter aortic valve replacement where conduction abnormalities are prevalent. It is crucial in managing patients with symptomatic bradycardia.
Evidence Summary
The available literature includes 15 studies, comprising randomized controlled trials, observational studies, and case series, published between 2019 and 2024. These studies explore the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report that the cardiovascular permanent pacemaker electrode effectively manages conduction abnormalities post-transcatheter aortic valve replacement. It is associated with improved cardiac function and reduced symptoms of bradycardia. Long-term outcomes indicate sustained pacing efficacy in diverse patient populations.
Safety Profile
Reported complications include the risk of lead dislodgement, infection at the implantation site, and device malfunction. Some studies highlight the potential for increased pacemaker dependency following certain cardiac procedures.
Evidence Limitations
The evidence is limited by the heterogeneity of study designs and patient populations. Further research is needed to explore long-term outcomes and device performance in specific subgroups, such as those with complex cardiac anatomies.
Frequently Asked Questions
What are the clinical indications for cardiovascular permanent pacemaker electrode?
The device is indicated for patients with symptomatic bradycardia, atrioventricular block, and post-transcatheter aortic valve replacement conduction abnormalities.
What outcomes have been reported in clinical studies?
Studies report effective management of conduction abnormalities and improved cardiac function, particularly post-transcatheter aortic valve replacement.
What complications have been reported?
Safety data indicate risks of lead dislodgement, infection, and device malfunction, with some patients experiencing increased pacemaker dependency.
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.