đź“‹ FDA Reference
agilis nxt steerable introducer model g408322 and g408323
St Jude Medical
Summary: The Agilis NXT Steerable Introducer is a medical device used to facilitate the placement of catheters in the heart. It is primarily used by cardiologists in electrophysiology procedures.
FDA Clearance Information
Pathway
510K
Number
K083402 ↗
Decision Date
December 15, 2008
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Agilis NXT Steerable Introducer, manufactured by St Jude Medical, was cleared through the FDA 510k pathway on December 15, 2008. It is a Class 2 device under product code DYB.
What It Is
The Agilis NXT Steerable Introducer is a specialized catheter introducer designed to provide enhanced control and precision when placing catheters within the heart. Its steerable sheath allows for improved navigation through the vascular system, particularly in complex cardiac anatomy. This device is crucial in procedures where precise catheter positioning is required, such as in electrophysiology studies and ablations.
Clinical Applications
This device is commonly used in electrophysiology labs during procedures like cardiac ablations, where precise catheter placement is critical. It is particularly beneficial in complex cases involving arrhythmias, where accurate navigation within the heart chambers is necessary. Cardiologists and electrophysiologists use this device in hospital settings, often in conjunction with other advanced cardiac mapping and ablation technologies.
Indications for Use
The Agilis NXT Steerable Introducer is indicated for use in patients requiring catheter-based interventions in the heart. It is especially useful for those undergoing procedures to treat arrhythmias, where precise catheter placement is essential.
Practical Considerations
The introducer is available in various sizes to accommodate different patient anatomies and catheter types. It is compatible with a range of electrophysiology catheters and requires careful handling to maximize its steerability and precision. Clinicians should be familiar with its operation to effectively utilize its full capabilities.
Frequently Asked Questions
What is the Agilis NXT Steerable Introducer used for?
It is used to facilitate the precise placement of catheters in the heart during electrophysiology procedures.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device in hospital electrophysiology labs.
What are the FDA-cleared indications?
It is indicated for use in catheter-based cardiac interventions, particularly for procedures addressing 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.