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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
510K
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.
Clinical Applications
Commonly used in procedures requiring transseptal access, such as mitral valve interventions and lead extractions, the device aids in navigating complex cardiac anatomies.
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.
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.