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electrode pacemaker permanent temporary
Intermedics
Summary: The electrode pacemaker by Intermedics is used for both permanent and temporary cardiac pacing. It is FDA-cleared and primarily used in managing arrhythmias. Key evidence highlights its role in reducing complications during procedures like TAVR.
FDA Clearance Information
Pathway
510K
Number
K870357 ↗
Decision Date
May 21, 1987
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510k pathway on May 21, 1987. Manufactured by Intermedics, it is classified as a Class 3 device under product code DTB.
What It Is
The electrode pacemaker is a medical device that delivers electrical impulses to the heart to regulate its rhythm. It is used in both permanent and temporary settings to manage arrhythmias and ensure adequate heart rate.
Clinical Applications
Commonly used in scenarios such as transcatheter aortic valve replacement (TAVR) and other cardiac procedures where temporary pacing is required. It is also used for permanent pacing in cases of chronic arrhythmias.
Evidence Summary
The literature includes 12 studies, ranging from randomized controlled trials to case series, published between 2014 and 2023. These studies explore the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report that the electrode pacemaker is effective in managing arrhythmias during procedures like TAVR. It has been shown to maintain adequate heart rates and reduce the incidence of conduction abnormalities post-procedure.
Safety Profile
Reported complications include cardiac tamponade from pacemaker perforation and lead migration. These are rare but serious events associated with temporary pacemaker use.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to explore long-term outcomes and compare efficacy with newer devices.
Frequently Asked Questions
What are the clinical indications for electrode pacemaker permanent temporary?
The device is indicated for managing arrhythmias, particularly during procedures like TAVR, and for patients with chronic bradyarrhythmias.
What outcomes have been reported in clinical studies?
Studies report effective management of arrhythmias and maintenance of heart rate during cardiac procedures, with reduced conduction abnormalities post-TAVR.
What complications have been reported?
Safety data indicate complications such as cardiac tamponade and lead migration, though these are rare occurrences.
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.