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stereotaxis catheter advancer system
Stereotaxis
Summary: The Stereotaxis catheter advancer system is a device used for remote-controlled catheter ablation, primarily in cardiac procedures. Key evidence shows successful ablation outcomes with minimal complications.
FDA Clearance Information
Pathway
510K
Number
K021802 ↗
Decision Date
April 8, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Stereotaxis catheter advancer system was cleared by the FDA via the 510(k) pathway on April 8, 2003. It is manufactured by Stereotaxis and classified as a Class 2 device.
What It Is
The Stereotaxis catheter advancer system is a medical device designed for remote-controlled catheter navigation and ablation. It is primarily used in electrophysiology to treat cardiac arrhythmias by enabling precise catheter positioning.
Clinical Applications
This device is commonly used in procedures involving catheter ablation of accessory pathways and atrioventricular nodal reentrant tachycardia (AVNRT). It provides a non-invasive approach to treat complex cardiac arrhythmias.
Evidence Summary
The available literature includes three studies, ranging from 2004 to 2007, comprising case series and other study types. These studies evaluate the feasibility, safety, and efficacy of the device in clinical settings.
Reported Outcomes
Published studies report successful catheter ablation of accessory pathways and AVNRT using the Stereotaxis system. One case series documented successful ablation of a right anterolateral accessory pathway. Another study highlighted the system's efficacy in modulating the slow pathway in the presence of a persistent left superior caval vein.
Safety Profile
Reported complications include no significant adverse events in the documented studies. The procedures were completed without any reported complications, indicating a favorable safety profile.
Evidence Limitations
The evidence is limited by the small number of studies and the predominance of case series, which may not provide comprehensive efficacy and safety data. Further research with larger, controlled trials is needed to validate these findings.
Frequently Asked Questions
What are the clinical indications for Stereotaxis catheter advancer system?
The device is indicated for use in remote-controlled catheter ablation procedures, particularly for treating cardiac arrhythmias such as accessory pathways and AVNRT.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful ablation of accessory pathways and AVNRT with minimal complications using the Stereotaxis system.
What complications have been reported?
Safety data from the evidence indicate no significant complications were reported in the studies reviewed.
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.