đź“Š Evidence-Based Reference
biotronik permanent pacemaker electrode
Biotronik Sales
Summary: The Biotronik permanent pacemaker electrode is a device used for cardiac pacing. It is primarily used in patients requiring permanent pacemaker implantation. Key evidence highlights its role in managing conduction disturbances post-cardiac interventions.
FDA Clearance Information
Pathway
510K
Number
K863480 ↗
Decision Date
September 23, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Biotronik permanent pacemaker electrode was cleared by the FDA via the 510(k) pathway on September 23, 1986. It is manufactured by Biotronik Sales and classified as a Class 3 device.
What It Is
The Biotronik permanent pacemaker electrode is designed to deliver electrical impulses to the heart to maintain an adequate heart rate. It is used in patients with conditions such as bradycardia or heart block, where the heart's natural pacing is insufficient.
Clinical Applications
This device is commonly used in clinical scenarios involving patients with atrioventricular block or after procedures like transcatheter valve replacements where conduction disturbances are anticipated. It ensures consistent cardiac pacing in these patients.
Evidence Summary
The available literature includes 12 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series. These studies span from 2024 to 2025, providing insights into the device's efficacy and safety.
Reported Outcomes
Published studies report that the Biotronik permanent pacemaker electrode effectively manages conduction disturbances following transcatheter valve interventions. It has been shown to reduce the incidence of high-grade atrioventricular block and the need for subsequent pacemaker implantation.
Safety Profile
Reported complications include the potential for high-grade atrioventricular block necessitating permanent pacemaker implantation. These complications are particularly noted following transcatheter tricuspid valve replacement procedures.
Evidence Limitations
Current evidence is limited by the short follow-up duration and the focus on specific cardiac interventions. Further research is needed to evaluate long-term outcomes and the device's performance across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Biotronik permanent pacemaker electrode?
The device is indicated for patients requiring permanent cardiac pacing due to conditions like bradycardia or heart block, particularly after cardiac interventions that may affect conduction.
What outcomes have been reported in clinical studies?
Studies have reported effective management of conduction disturbances and reduced need for additional pacemaker implantation following cardiac procedures.
What complications have been reported?
Safety data indicate complications such as high-grade atrioventricular block, particularly after transcatheter valve replacements, necessitating permanent pacemaker implantation.
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.