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agilis es steerable introducer
St Jude Medical
Summary: The Agilis ES Steerable Introducer is a medical device used primarily in cardiac procedures to facilitate catheter navigation. It is commonly used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K103083 ↗
Decision Date
April 8, 2011
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Agilis ES Steerable Introducer was cleared through the FDA 510(k) pathway on April 8, 2011. Manufactured by St Jude Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Agilis ES Steerable Introducer is a specialized catheter introducer designed to provide precise control and maneuverability during cardiac procedures. It features a steerable sheath that allows clinicians to navigate complex vascular pathways, enhancing the delivery of diagnostic and therapeutic catheters. This device is particularly useful in procedures requiring high precision, such as electrophysiology studies and catheter ablations.
Clinical Applications
This device is commonly used in interventional cardiology and electrophysiology labs, particularly during procedures like atrial fibrillation ablations and other complex arrhythmia treatments. It is utilized by cardiologists and electrophysiologists to improve access to the heart's chambers, facilitating the placement of catheters in challenging anatomical locations. The device is suitable for adult patients undergoing cardiac interventions.
Indications for Use
The FDA-cleared indications for the Agilis ES Steerable Introducer include its use in procedures that require precise catheter positioning within the heart. This is particularly relevant for patients undergoing treatments for cardiac arrhythmias, where accurate catheter placement is critical.
Practical Considerations
The Agilis ES Steerable Introducer is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and is designed for use with standard vascular access techniques. Clinicians should be familiar with its steering mechanism to maximize its utility during procedures.
Frequently Asked Questions
What is the Agilis ES Steerable Introducer used for?
It is used to facilitate precise catheter navigation during cardiac procedures, such as electrophysiology studies and ablations.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device during interventional cardiac procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring precise catheter positioning in the heart, particularly for treating 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.