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carto vizigo 8 5f bi-directional guiding sheath
Biosense Webster
Summary: The Carto Vizigo 8.5F Bi-Directional Guiding Sheath is a medical device used in electrophysiology procedures to guide catheters within the heart. It is primarily used by cardiologists specializing in electrophysiology.
FDA Clearance Information
Pathway
510K
Number
K170997 ↗
Decision Date
July 25, 2017
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Carto Vizigo 8.5F Bi-Directional Guiding Sheath was cleared via the FDA 510(k) pathway on July 25, 2017. It is manufactured by Biosense Webster and classified as a Class 2 medical device.
What It Is
The Carto Vizigo 8.5F Bi-Directional Guiding Sheath is a specialized catheter sheath designed to facilitate the navigation and placement of electrophysiology catheters within the heart. Its bi-directional steering capability allows for precise control and positioning, which is crucial during complex cardiac mapping and ablation procedures. The sheath is compatible with various catheter systems, enhancing its versatility in clinical settings.
Clinical Applications
This device is commonly used in electrophysiology labs during procedures such as catheter ablation for arrhythmias, including atrial fibrillation and ventricular tachycardia. It is utilized by electrophysiologists to improve catheter stability and maneuverability, particularly in challenging anatomical regions of the heart. The sheath's design aids in reducing procedure time and enhancing the accuracy of catheter placement.
Indications for Use
The Carto Vizigo 8.5F Bi-Directional Guiding Sheath is indicated for use in guiding catheters during electrophysiological procedures. It is particularly beneficial for patients undergoing complex ablation therapies for cardiac arrhythmias.
Practical Considerations
The sheath typically comes in an 8.5F size, which is compatible with a wide range of electrophysiology catheters. Its bi-directional steering mechanism requires familiarity for optimal use, and clinicians should ensure compatibility with their existing catheter systems. Proper technique is essential to maximize the device's benefits and minimize potential complications.
Frequently Asked Questions
What is the Carto Vizigo 8.5F Bi-Directional Guiding Sheath used for?
It is used to guide catheters during electrophysiological procedures, primarily for cardiac mapping and ablation.
What specialties typically use this device?
Electrophysiologists and cardiologists specializing in cardiac arrhythmia management typically use this device.
What are the FDA-cleared indications?
The device is indicated for guiding catheters during electrophysiology procedures, especially in the treatment of cardiac arrhythmias.
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.