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agilis nxt steerable introducer
St Jude Medical
Summary: The Agilis NxT Steerable Introducer is a medical device used primarily for cardiac procedures requiring precise catheter placement. Key evidence highlights its role in facilitating complex transseptal interventions.
FDA Clearance Information
Pathway
510K
Number
K083083 ↗
Decision Date
November 6, 2008
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Agilis NxT Steerable Introducer, manufactured by St Jude Medical, received FDA clearance via the 510(k) pathway on November 6, 2008. It is classified as a Class 2 device under product code DYB.
What It Is
The Agilis NxT Steerable Introducer is designed to aid in the placement of catheters within the heart. It features a steerable tip that allows for precise navigation and positioning, making it suitable for complex cardiac procedures.
Clinical Applications
Commonly used in procedures such as transseptal catheterization and lead extraction, the Agilis NxT Steerable Introducer provides enhanced control and flexibility, facilitating access to challenging cardiac structures.
Evidence Summary
The literature includes a mix of case series and other study types, with a total of 7 studies ranging from 2021 to 2024. These studies explore various applications of the device in cardiac interventions.
Reported Outcomes
Published studies report that the Agilis NxT Steerable Introducer is 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 factor in its efficacy.
Safety Profile
Reported complications include challenges associated with lead extraction and the need for alternative techniques in cases of unsuccessful initial attempts. However, specific adverse events related to the device itself are not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials and a focus on case series and retrospective analyses. Further research is needed to establish standardized protocols and long-term outcomes.
Frequently Asked Questions
What are the clinical indications for Agilis NxT Steerable Introducer?
The device is indicated for use in cardiac procedures requiring precise catheter placement, such as transseptal catheterization and lead extraction.
What outcomes have been reported in clinical studies?
Studies report successful facilitation of complex cardiac procedures, with the device's steerability being a significant factor in its effectiveness.
What complications have been reported?
Safety data indicate challenges with lead extraction and the necessity for alternative techniques, though specific device-related adverse events are 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.