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agilis nxt steerable introducer
St Jude Medical
Summary: The Agilis NxT Steerable Introducer is a device used for precise catheter placement in cardiac procedures. It is primarily used in transseptal access for electrophysiology interventions. Key evidence highlights its role in facilitating complex procedures like mitral paravalvular leak closure.
FDA Clearance Information
Pathway
510K
Number
K061363 ↗
Decision Date
July 12, 2006
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Agilis NxT Steerable Introducer was cleared via the FDA 510(k) pathway on July 12, 2006. It is manufactured by St Jude Medical and classified as a Class 2 medical device under product code DYB.
What It Is
The Agilis NxT Steerable Introducer is a catheter-based device designed to provide steerable access to the heart's chambers. It is primarily used in electrophysiology procedures to facilitate transseptal access, allowing for precise catheter placement.
Clinical Applications
Common clinical scenarios for the Agilis NxT include transseptal catheterization during electrophysiology studies and interventions, such as atrial fibrillation ablation and mitral valve repair. It is particularly useful in complex cardiac procedures requiring precise navigation.
Evidence Summary
The available literature includes a mix of case series, retrospective studies, and clinical trials, with a total of 7 studies identified. These studies range from 2021 to 2024, highlighting the device's application in various cardiac procedures.
Reported Outcomes
Published studies report that the Agilis NxT Steerable Introducer facilitates complex cardiac procedures, such as transseptal transcatheter closure of mitral paravalvular leaks. It has been shown to improve procedural success rates in challenging cases where conventional methods are inadequate.
Safety Profile
Reported complications include potential risks associated with transseptal access, such as cardiac perforation and vascular injury. However, specific adverse events related to the Agilis NxT were not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term safety and efficacy outcomes, as well as to explore its use in broader clinical settings.
Frequently Asked Questions
What are the clinical indications for Agilis NxT Steerable Introducer?
The Agilis NxT is indicated for use in transseptal catheterization during electrophysiology procedures, such as atrial fibrillation ablation and mitral valve repair.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved procedural success in complex cardiac interventions, such as mitral paravalvular leak closure, using the Agilis NxT.
What complications have been reported?
Reported complications include risks associated with transseptal access, such as cardiac perforation and vascular injury, though specific adverse events related to the device were not detailed.
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.