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agilis nxt steerable introducer
St Jude Medical
Summary: The Agilis NxT Steerable Introducer by St Jude Medical is a device used to facilitate catheter navigation in complex cardiac procedures. Key evidence highlights its role in transseptal procedures and lead extraction techniques.
FDA Clearance Information
Pathway
510K
Number
K110450 ↗
Decision Date
May 10, 2011
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Agilis NxT Steerable Introducer was cleared by the FDA via the 510(k) pathway on May 10, 2011. It is manufactured by St Jude Medical and is classified as a Class 2 device under product code DYB.
What It Is
The Agilis NxT Steerable Introducer is a medical device designed to aid in the navigation of catheters during cardiac procedures. It features a steerable mechanism that allows for precise control and positioning, making it suitable for complex interventions.
Clinical Applications
This device is commonly used in procedures requiring transseptal access, such as mitral valve interventions and electrophysiological studies. It is also employed in lead extraction techniques where precise catheter manipulation is critical.
Evidence Summary
The literature includes a mix of study types, such as case series and retrospective analyses, with a total of 7 studies identified. The studies span from 2021 to 2024, providing insights into the device's application in various cardiac procedures.
Reported Outcomes
Published studies report the Agilis NxT Steerable Introducer as effective in facilitating transseptal procedures and aiding in lead extraction techniques. It has been shown to improve procedural success rates in challenging cardiac interventions.
Safety Profile
Reported complications include challenges in lead extraction and potential procedural difficulties. 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 lack of large-scale randomized controlled trials. Most studies are case series or retrospective analyses, which may introduce bias. Further research is needed to establish comprehensive safety and efficacy profiles.
Frequently Asked Questions
What are the clinical indications for Agilis NxT Steerable Introducer?
The device is indicated for use in procedures requiring precise catheter navigation, such as transseptal access for mitral valve interventions and lead extraction.
What outcomes have been reported in clinical studies?
Studies report improved procedural success rates in transseptal and lead extraction procedures facilitated by the Agilis NxT Steerable Introducer.
What complications have been reported?
Reported complications include procedural challenges, 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.