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coaxial bipolar pacing electrode
Burditt & Calkins-Siemens-Elema
Summary: The coaxial bipolar pacing electrode by Burditt & Calkins-Siemens-Elema is a device used for cardiac pacing. Key evidence highlights its safety in MRI settings with no major adverse events reported.
FDA Clearance Information
Pathway
510K
Number
K822239 ↗
Decision Date
October 4, 1982
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The coaxial bipolar pacing electrode was cleared by the FDA via the 510(k) pathway on October 4, 1982. It is manufactured by Burditt & Calkins-Siemens-Elema and classified as a Class 3 device.
What It Is
The coaxial bipolar pacing electrode is designed for cardiac pacing, utilizing a coaxial design to deliver electrical impulses to the heart. It is intended for use in patients requiring temporary or permanent cardiac pacing.
Clinical Applications
This device is commonly used in scenarios requiring temporary cardiac pacing, such as during cardiac surgery or in patients with bradycardia. It provides reliable electrical conduction to maintain heart rhythm.
Evidence Summary
The literature includes 10 studies, with a mix of retrospective and other study types, spanning from 1999 to 2025. These studies explore various aspects of the device's safety and efficacy.
Reported Outcomes
Published studies report that the coaxial bipolar pacing electrode is effective in maintaining cardiac rhythm during procedures. A study on MRI safety found no major adverse events, indicating the device's compatibility with MRI environments.
Safety Profile
Reported complications include one minor sensory event during an MRI, with no major adverse events noted in the studies. The device is generally considered safe for use in MRI settings.
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 efficacy in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for coaxial bipolar pacing electrode?
The device is indicated for use in patients requiring temporary or permanent cardiac pacing.
What outcomes have been reported in clinical studies?
Studies report effective pacing and maintenance of cardiac rhythm, with no major adverse events in MRI settings.
What complications have been reported?
Safety data indicate one minor sensory event during MRI, with no major adverse events reported.
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.