📊 Evidence-Based Reference
Agilis Nxt Steerable Introducer Dual-Reach I-V2-Med
Abbott Medical
Summary: The Agilis NxT Steerable Introducer by Abbott Medical is a device used for precise catheter placement in cardiac procedures. Key evidence highlights its role in facilitating complex transseptal procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K241370 ↗
Decision Date ?
June 13, 2024
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Agilis NxT Steerable Introducer received FDA 510(k) clearance on June 13, 2024. Manufactured by Abbott Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Agilis NxT Steerable Introducer is a catheter-based device designed to provide enhanced maneuverability and precision during cardiac procedures. It is primarily used to facilitate transseptal access and catheter positioning.
FDA-Cleared Indications
- Used to introduce, guide, and support diagnostic and therapeutic catheters during cardiac procedures.
- Designed to facilitate catheter placement and exchange within the heart and vascular system.
- Intended for use by physicians trained in cardiac catheterization and related interventional procedures.
Clinical Applications
- Transseptal access and catheter positioning during left-sided cardiac procedures.
- Electrophysiology procedures requiring directed catheter navigation within the atria or ventricles.
- Placement or exchange of compatible cardiac diagnostic and therapeutic catheters.
- Catheter-based treatment procedures involving complex cardiac anatomy.
Reported off-label uses
- Use as a steerable support sheath for selected structural-heart or cardiac-device procedures beyond the specific cleared labeling.
- Use in selected lead-extraction or complex venous-access cases when the operator determines that the device is appropriate.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes 7 studies ranging from 2019 to 2024, encompassing various methodologies such as RCTs, case series, and retrospective analyses. These studies explore the device's application in cardiac interventions.
Reported Outcomes
Published studies report the Agilis NxT Steerable Introducer as effective in facilitating complex cardiac procedures, such as transseptal transcatheter closure of mitral paravalvular leaks and lead extractions. The device's steerability is highlighted as a key advantage.
Safety Profile
Reported complications include challenges in lead grasping during extractions and the need for alternative techniques in certain scenarios. Overall, the device is considered safe with a low incidence of adverse events.
Evidence Limitations
Evidence gaps include limited large-scale RCTs and a need for more comprehensive safety data. Further research is required to establish long-term outcomes and refine procedural techniques.
Practical Considerations
- The device is available in model-specific configurations, including the Dual-Reach I-V2-MED version; users should confirm the French size, usable length, curve range, and inner diameter before the procedure.
- Only catheters and guidewires compatible with the introducer's inner diameter and length should be used.
- The sheath is manipulated under fluoroscopic and, when appropriate, intracardiac or transesophageal echocardiographic guidance.
- Potential complications include vascular injury, bleeding, hematoma, infection, air or thrombus embolization, arrhythmia, cardiac perforation, and pericardial effusion or tamponade.
- MRI compatibility depends on the exact model and labeling; the device should not be assumed to be MRI safe or conditional without checking the current Abbott instructions for use.
Frequently Asked Questions
What are the clinical indications for Agilis NxT Steerable Introducer?
The device is indicated for use in procedures requiring precise catheter placement, such as transseptal access for mitral valve interventions and lead extractions.
What outcomes have been reported in clinical studies?
Studies report successful facilitation of complex cardiac procedures, with the device's steerability enhancing procedural outcomes.
What complications have been reported?
Safety data indicate challenges in lead grasping and the necessity for alternative techniques, though adverse events are generally low.
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.