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electrode pacemaker permanent
Pacesetter Systems
Summary: The electrode pacemaker permanent by Pacesetter Systems is a device used for cardiac pacing. It is primarily used in patients requiring permanent pacing solutions. Key evidence highlights successful implant rates and stable pacing performance.
FDA Clearance Information
Pathway
510K
Number
K823033 ↗
Decision Date
December 30, 1982
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The electrode pacemaker permanent was cleared by the FDA through the 510(k) pathway on December 30, 1982. It is manufactured by Pacesetter Systems and classified as a Class III device.
What It Is
The electrode pacemaker permanent is a cardiac device designed to regulate heartbeats in patients with arrhythmias. It functions by delivering electrical impulses to the heart muscles, ensuring proper heart rhythm and rate.
Clinical Applications
This device is commonly used in patients with bradycardia or other conditions requiring permanent cardiac pacing. It is often considered in scenarios where traditional pacing methods are insufficient or contraindicated.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, prospective, and retrospective studies, spanning from 2020 to 2024. These studies explore various aspects of pacemaker efficacy and safety.
Reported Outcomes
Published studies report that leadless pacemaker systems, including the electrode pacemaker permanent, demonstrate highly successful implant rates and stable pacing performance. They are effective in reducing complications associated with traditional transvenous pacemakers.
Safety Profile
Reported complications include pacemaker malfunctions, infections at the pacemaker pocket, and cardiac tamponade. These adverse events highlight the need for careful monitoring and management in clinical practice.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of long-term follow-up data. Further research is needed to explore the long-term safety and efficacy of these devices in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for electrode pacemaker permanent?
The clinical indications include bradycardia and other arrhythmias requiring permanent pacing solutions, as outlined in the FDA documentation.
What outcomes have been reported in clinical studies?
Studies report successful implant rates and stable pacing performance, with reduced complications compared to traditional pacemakers.
What complications have been reported?
Safety data indicate complications such as pacemaker malfunctions, infections, and cardiac tamponade.
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.