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performer introducer
Cook
Summary: The performer introducer by Cook is a medical device used primarily for embolization-coils. It was FDA cleared via the 510k pathway in 2017. Key evidence highlights its role in improving procedural success rates.
FDA Clearance Information
Pathway
510K
Number
K173068 ↗
Decision Date
November 17, 2017
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The performer introducer was cleared by the FDA through the 510k pathway on November 17, 2017. It is manufactured by Cook and classified as a Class 2 device under product code DYB.
What It Is
The performer introducer is a medical device designed to facilitate the introduction of embolization coils into the vasculature. It is used in interventional radiology to aid in the precise placement of coils for embolization procedures.
Clinical Applications
Commonly used in interventional radiology, the performer introducer assists in procedures requiring the placement of embolization coils, such as treating aneurysms or vascular malformations. It provides a conduit for delivering coils to the target site.
Evidence Summary
The available literature includes 14 studies, encompassing various study types such as RCTs, systematic reviews, and case series, with publication years ranging from 2023 to 2024. These studies explore the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the performer introducer enhances procedural success rates in embolization procedures. It has been associated with improved accuracy in coil placement and reduced procedure time. The device's design facilitates easier navigation through the vasculature.
Safety Profile
Reported complications include airway trauma associated with tracheal tube introducers and potential dislodgment during procedures. However, the performer introducer itself has not been directly linked to significant adverse events in the reviewed studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term follow-up data in some studies. Further research is needed to establish comprehensive safety profiles and to explore the device's efficacy in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for performer introducer?
The performer introducer is indicated for use in embolization procedures, particularly for the placement of embolization coils in interventional radiology.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved procedural success rates, enhanced accuracy in coil placement, and reduced procedure times when using the performer introducer.
What complications have been reported?
Safety data indicate potential complications such as airway trauma with tracheal tube introducers and dislodgment during procedures, though these are not directly linked to the performer introducer.
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.