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cardiovascular permanent pacemaker electrode
Siemens-Pacesetter
Summary: The cardiovascular permanent pacemaker electrode by Siemens-Pacesetter is a device used for cardiac pacing. It is primarily used in patients with conduction abnormalities. Key evidence highlights its role post-transcatheter aortic valve replacement.
FDA Clearance Information
Pathway
510K
Number
K920822 ↗
Decision Date
January 22, 1993
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on January 22, 1993. It is manufactured by Siemens-Pacesetter and classified as a Class 3 medical device.
What It Is
The cardiovascular permanent pacemaker electrode is designed to deliver electrical impulses to the heart to maintain an adequate heart rate. It is used in patients with bradycardia or heart block to ensure proper cardiac function.
Clinical Applications
This device is commonly used in patients with conduction abnormalities, such as those occurring after transcatheter aortic valve replacement (TAVR). It is also indicated for patients with atrioventricular block or other forms of bradycardia.
Evidence Summary
The literature includes 15 studies, comprising RCTs, 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 pacemaker electrode effectively manages conduction abnormalities, particularly after TAVR. It has been shown to reduce symptoms associated with bradycardia and improve patient outcomes in the long term.
Safety Profile
Reported complications include conduction abnormalities such as high-grade atrioventricular block and new onset left bundle branch block. These are common post-TAVR and may necessitate pacemaker implantation.
Evidence Limitations
The evidence is limited by the variability in study designs and patient populations. Further research is needed to explore long-term outcomes and device performance in diverse clinical scenarios.
Frequently Asked Questions
What are the clinical indications for cardiovascular permanent pacemaker electrode?
The device is indicated for patients with bradycardia, heart block, and conduction abnormalities, particularly following procedures like TAVR.
What outcomes have been reported in clinical studies?
Studies have reported improved management of conduction abnormalities and symptom reduction in patients with bradycardia.
What complications have been reported?
Safety data indicate complications such as high-grade atrioventricular block and new onset left bundle branch block, especially post-TAVR.
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.