📊 Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitates the introduction and placement of embolization coils into the vascular system.
- Used as an introducer during endovascular embolization procedures.
Clinical Applications
- Providing vascular access for embolization-coil delivery.
- Supporting endovascular treatment of vascular abnormalities when coil embolization is indicated.
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.
Practical Considerations
- Use requires compatibility with the selected guidewire, catheter, embolization coil system, and vascular access sheath.
- The appropriate device size and length depend on the access vessel, target anatomy, catheter system, and embolization technique.
- The device is used under fluoroscopic or other appropriate imaging guidance by trained endovascular specialists.
- MRI safety and conditional-use information should be confirmed in the current manufacturer labeling; do not assume the device is MRI safe.
- Contraindications, warnings, and handling instructions should be reviewed in the current FDA-cleared labeling before use.
Procedures that use this device
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.