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transglidext expandable introducer
Transaortic Medical
Summary: The Transglidext Expandable Introducer by Transaortic Medical is a device used in embolization procedures. It was FDA cleared via the 510k pathway in 2019. Key evidence includes studies on its use in various clinical scenarios.
FDA Clearance Information
Pathway
510K
Number
K181817 ↗
Decision Date
March 26, 2019
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Transglidext Expandable Introducer was cleared by the FDA through the 510k pathway on March 26, 2019. It is manufactured by Transaortic Medical and classified as a Class 2 device.
What It Is
The Transglidext Expandable Introducer is a medical device designed to facilitate the introduction of embolization coils into the vascular system. It is used in interventional radiology and cardiology to treat vascular abnormalities.
Clinical Applications
Commonly used in procedures requiring the placement of embolization coils, the Transglidext Expandable Introducer is utilized in treating conditions such as aneurysms and arteriovenous malformations. It provides a minimally invasive option for vascular interventions.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series. These studies span from 2022 to 2025, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report varied outcomes, including successful deployment of embolization coils and effective management of vascular conditions. The device has shown efficacy in reducing procedural times and improving patient recovery in certain cases.
Safety Profile
Reported complications include device-related vascular injuries and minor bleeding events. Overall, the safety profile is consistent with other devices in its class, with no significant increase in adverse events reported.
Evidence Limitations
Current evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to establish the device's efficacy across diverse patient populations and to evaluate long-term outcomes.
Frequently Asked Questions
What are the clinical indications for Transglidext Expandable Introducer?
The device is indicated for use in embolization procedures to treat vascular abnormalities such as aneurysms and arteriovenous malformations.
What outcomes have been reported in clinical studies?
Studies have reported successful coil deployment and effective management of vascular conditions, with improvements in procedural efficiency.
What complications have been reported?
Safety data indicate complications such as vascular injuries and minor bleeding events, consistent with similar devices.
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.