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agilis nxt steerable introducer dual-reach
Abbott Medical
Summary: The Agilis NxT Steerable Introducer Dual-Reach by Abbott Medical is a device used primarily for transseptal access in cardiac procedures. Key evidence highlights its role in facilitating complex interventions such as mitral paravalvular leak closure.
FDA Clearance Information
Pathway
510K
Number
K243493 ↗
Decision Date
December 13, 2024
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Agilis NxT Steerable Introducer Dual-Reach received FDA clearance through the 510(k) pathway on December 13, 2024. It is manufactured by Abbott Medical and classified as a Class 2 device.
What It Is
The Agilis NxT Steerable Introducer Dual-Reach is a medical device designed to provide steerable access to the heart during interventional procedures. It is primarily used for transseptal catheterization, allowing precise navigation and positioning within the cardiac chambers.
Clinical Applications
Common clinical scenarios for the Agilis NxT include transseptal access for mitral valve interventions, lead extractions, and complex cardiac procedures requiring precise catheter placement. It is particularly useful in cases where traditional access methods are challenging.
Evidence Summary
The available literature includes 7 studies, comprising various study types such as RCTs, case series, and retrospective analyses. The studies span from 2019 to 2024, providing insights into the device's clinical applications and outcomes.
Reported Outcomes
Published studies report that the Agilis NxT Steerable Introducer facilitates successful transseptal access and complex cardiac interventions, such as mitral paravalvular leak closure. It has been shown to improve procedural success rates in challenging cases.
Safety Profile
Reported complications include potential difficulties in lead extraction and procedural challenges in complex cardiac interventions. However, specific adverse events related to the device itself are not extensively documented in the provided evidence.
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, as well as to explore additional clinical applications.
Frequently Asked Questions
What are the clinical indications for Agilis NxT Steerable Introducer Dual-Reach?
The device is indicated for use in transseptal access during cardiac procedures, particularly in complex interventions such as mitral valve repairs and lead extractions.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved procedural success rates in complex cardiac interventions, such as mitral paravalvular leak closures, facilitated by the device's steerability.
What complications have been reported?
Safety data from evidence indicate potential procedural challenges and difficulties in lead extraction, but specific adverse events related to the device are not extensively documented.
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.