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braided guiding introducer
Thomas Medical Products
Summary: The braided guiding introducer by Thomas Medical Products is a device used primarily in embolization procedures. Key evidence highlights its use in complex vascular scenarios, with studies exploring its application in intracranial aneurysms.
FDA Clearance Information
Pathway
510K
Number
K004026 ↗
Decision Date
July 9, 2001
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The braided guiding introducer received FDA clearance through the 510(k) pathway on July 9, 2001. It is manufactured by Thomas Medical Products and is classified as a Class 2 device under product code DYB.
What It Is
The braided guiding introducer is a medical device designed to facilitate the introduction of catheters and other instruments into the vascular system. It is primarily used in embolization procedures, providing stability and support in complex vascular pathways.
Clinical Applications
This device is commonly used in procedures involving embolization coils, particularly in cases where vascular access is challenging due to tortuous anatomy. It is utilized in both peripheral and neurovascular interventions.
Evidence Summary
The available literature includes two studies, with publication years ranging from 2007 to 2022. These studies encompass various methodologies, including case reports and prospective analyses, focusing on the device's application in vascular interventions.
Reported Outcomes
Published studies report that the braided guiding introducer is effective in providing stable access for endovascular procedures, particularly in challenging vascular anatomies. Its use in intracranial aneurysm treatment has been documented, highlighting its role in successful catheter placement.
Safety Profile
Reported complications include the potential for embolization of device fragments, as noted in a case report. However, detailed safety profiles and adverse event rates are not extensively covered in the available literature.
Evidence Limitations
The evidence base is limited, with only two studies providing insights into the device's use. Further research is needed to establish comprehensive safety and efficacy profiles, particularly in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for braided guiding introducer?
The braided guiding introducer is indicated for use in embolization procedures, particularly in cases requiring stable vascular access in complex anatomies.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful catheter placement and stable access in endovascular treatments, particularly for intracranial aneurysms.
What complications have been reported?
Safety data from evidence indicates potential complications such as embolization of device fragments, though detailed adverse event rates 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.