đź“‹ FDA Reference
agilis nxt steerable introducer model g408324
St Jude Medical
Summary: The Agilis NXT Steerable Introducer is a medical device used to facilitate catheter navigation in complex cardiac procedures. It is primarily used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K081645 ↗
Decision Date
December 9, 2008
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Agilis NXT Steerable Introducer, manufactured by St Jude Medical, was cleared by the FDA via the 510k pathway on December 9, 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 maneuverability during cardiac procedures. It features a steerable tip that allows precise navigation through the vascular system, making it particularly useful in complex electrophysiological interventions. The device is engineered to support the introduction and positioning of various diagnostic and therapeutic catheters.
Clinical Applications
This device is commonly used in electrophysiology labs during procedures such as catheter ablation for arrhythmias. It is particularly valuable in settings where precise catheter placement is critical, such as in the treatment of atrial fibrillation or ventricular tachycardia. The introducer is typically used in adult patients undergoing cardiac interventions, and it is a staple in the toolkit of cardiologists and electrophysiologists.
Indications for Use
The FDA indications for the Agilis NXT Steerable Introducer include its use in facilitating the introduction and positioning of catheters within the heart. It is intended for patients undergoing procedures that require precise catheter navigation, such as those with arrhythmias.
Practical Considerations
The Agilis NXT is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters, and clinicians should be familiar with its steering mechanism to optimize its use. Proper training in its handling is recommended to ensure procedural success.
Frequently Asked Questions
What is the Agilis NXT Steerable Introducer used for?
It is used to facilitate the navigation and placement of catheters during complex cardiac procedures, particularly in electrophysiology.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device in cardiac catheterization and electrophysiology labs.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction and positioning of catheters within the heart during procedures requiring precise navigation.
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.