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medamicus percutaneous introducer
Medamicus
Summary: The Medamicus Percutaneous Introducer is a Class 2 medical device used primarily for vascular access in embolization procedures. Key evidence highlights its effectiveness in reducing complications associated with traditional techniques.
FDA Clearance Information
Pathway
510K
Number
K951313 ↗
Decision Date
June 27, 1995
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Medamicus Percutaneous Introducer was cleared by the FDA via the 510(k) pathway on June 27, 1995. It is manufactured by Medamicus and classified as a Class 2 device.
What It Is
The Medamicus Percutaneous Introducer is designed to facilitate vascular access for procedures such as embolization. It provides a conduit for the insertion of catheters or other devices into the vascular system.
Clinical Applications
Commonly used in interventional radiology, the device is employed in scenarios requiring precise vascular access, such as in the placement of embolization coils. It is particularly useful in cases where traditional access methods are contraindicated.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series. These studies span from 2020 to 2022, providing a comprehensive overview of the device's clinical utility.
Reported Outcomes
Published studies report that the Medamicus Percutaneous Introducer is effective in facilitating vascular access with a high success rate. It is associated with improved procedural outcomes compared to traditional methods, particularly in complex cases.
Safety Profile
Reported complications include radial artery spasm and occlusion, particularly when used inappropriately sized arteries. However, the device is generally considered safe when used according to guidelines.
Evidence Limitations
While the evidence supports the device's efficacy, there are gaps in long-term outcome data. Further research is needed to explore its use in diverse patient populations and to establish standardized protocols for its application.
Frequently Asked Questions
What are the clinical indications for Medamicus Percutaneous Introducer?
The device is indicated for use in vascular access procedures, particularly in embolization and other interventional radiology applications.
What outcomes have been reported in clinical studies?
Studies report high success rates in vascular access and improved procedural outcomes compared to traditional techniques.
What complications have been reported?
Safety data indicate potential complications such as radial artery spasm and occlusion, especially in cases of artery-sheath size mismatch.
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.