📊 Evidence-Based Reference
Firststic N Introducer
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Summary: The firststic n introducer by Argon Medical Devices is a Class 2 device used in embolization procedures. It was FDA cleared via the 510(k) pathway. Key evidence highlights its role in achieving optimal implant-cement interfaces and its use in embolization procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K141969 ↗
Decision Date ?
December 19, 2014
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The firststic n introducer was cleared by the FDA through the 510(k) pathway on December 19, 2014. It is manufactured by Argon Medical Devices and classified as a Class 2 device.
What It Is
The firststic n introducer is a medical device designed to facilitate the introduction of embolization coils during interventional procedures. It is used to assist in the precise placement of coils to occlude blood vessels, primarily in embolization procedures.
FDA-Cleared Indications
- Used to facilitate the introduction and delivery of embolization coils during embolization procedures.
- Intended for use in the vasculature when controlled placement of embolization coils is required.
Clinical Applications
- Delivery of embolization coils to target blood vessels.
- Catheter-based embolization for management of abnormal or unwanted blood flow.
- Embolization procedures requiring controlled coil placement under fluoroscopic imaging.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and case series, with publication years ranging from 2024 to 2025. These studies explore the device's application in embolization and its role in achieving optimal implant-cement interfaces.
Reported Outcomes
Published studies report that the firststic n introducer is effective in facilitating embolization procedures, particularly in complex vascular scenarios. It has been shown to aid in achieving optimal implant-cement interfaces, which is crucial for the success of certain surgical interventions.
Safety Profile
Reported complications include challenges in achieving a conforming implant-cement interface, which can impact the success of procedures. However, specific adverse events directly related to the use of the firststic n introducer were not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of detailed safety outcomes and specific adverse event reporting. Further research is needed to establish comprehensive safety profiles and long-term efficacy data for the firststic n introducer.
Practical Considerations
- The introducer must be used with compatible embolization coils and delivery components; exact compatibility depends on the device model and size.
- Use is performed under fluoroscopic or other appropriate image guidance by trained clinicians.
- The access site, catheter pathway, and target vessel determine the appropriate size and configuration; consult the current manufacturer instructions for use.
- MRI safety status should be confirmed from the current product labeling. Do not assume MRI compatibility based only on the device name.
- Potential risks are related to vascular access, catheterization, and embolization, including bleeding, infection, vessel injury, non-target embolization, ischemia, and device malfunction.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for firststic n introducer?
The firststic n introducer is indicated for use in embolization procedures, particularly for the delivery of embolization coils in vascular interventions.
What outcomes have been reported in clinical studies?
Studies have reported the device's effectiveness in facilitating embolization and achieving optimal implant-cement interfaces.
What complications have been reported?
Reported complications include challenges in achieving a conforming implant-cement interface, though specific adverse events 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.