đź“‹ FDA Reference
Agilis Nxt Steerable Introducer Model G408324
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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitate the introduction of catheters into the heart and coronary vasculature.
- Provide directional control and support for positioning diagnostic or therapeutic catheters during cardiac procedures.
Clinical Applications
- Introduction and positioning of electrophysiology catheters during cardiac mapping.
- Support for catheter-based treatment of cardiac arrhythmias, including ablation procedures, when consistent with the device labeling.
- Navigation of catheters within the right or left heart during interventional cardiac procedures.
Practical Considerations
- The device is available in different sizes and curve configurations; the appropriate model depends on the target anatomy, catheter diameter and procedure.
- It is advanced through a vascular access sheath or vessel and manipulated under fluoroscopic or other appropriate imaging guidance by trained clinicians.
- Compatibility must be confirmed with the intended guidewire, catheter, hemostasis valve and other procedural equipment.
- MRI safety depends on the exact model and labeling. Confirm the current manufacturer instructions before an MRI examination; do not assume the device is MRI safe.
- Contraindications, warnings and handling instructions should be reviewed in the current manufacturer labeling. Potential concerns include vascular injury, bleeding, thrombosis, infection, arrhythmia and cardiac perforation.
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.