đź“‹ FDA Reference

transglide expandable introducer

Transaortic Medical

Summary: The Transglide Expandable Introducer is a medical device used to facilitate the insertion of embolization coils. It is primarily used by interventional cardiologists and radiologists.

FDA Clearance Information

Pathway 510K
Decision Date April 7, 2016
Product Code DYB
Device Class Class 2
Evidence 0 studies

The Transglide Expandable Introducer was cleared via the FDA 510(k) pathway on April 7, 2016. Manufactured by Transaortic Medical, it is classified as a Class 2 device.

What It Is

The Transglide Expandable Introducer is an expandable sheath designed to aid in the insertion of medical devices such as embolization coils. It features a unique expandable mesh component that reduces the inner diameter, allowing for less invasive access. This design helps minimize vascular trauma and improves patient outcomes during procedures requiring vascular access.

Clinical Applications

This device is commonly used in procedures requiring vascular access, such as the implantation of embolization coils. It is particularly useful in interventional cardiology and radiology settings, where minimizing vascular trauma is crucial. The device is suitable for patients undergoing procedures that require femoral access, especially when a reduced sheath size is advantageous.

Indications for Use

The Transglide Expandable Introducer is indicated for use in procedures that require the introduction of embolization coils into the vascular system. It is designed for patients needing vascular interventions where minimizing access size is beneficial.

Practical Considerations

The device's expandable design allows it to accommodate a range of device sizes while minimizing the sheath's inner diameter. Clinicians should be aware of the compatibility with other devices and consider the reduced trauma benefits when selecting this introducer for vascular access.

Related Literature

A multicenter registry study in 2019 evaluated the use of the Transglide Expandable Introducer's mesh component for femoral access during the implantation of the ACURATE neo prosthesis. The study found that using the Meshonly component reduced the inner diameter to 13 French, compared to standard sheaths up to 20 French. The findings suggested feasibility and safety, though the study's limitations include its observational nature and potential selection bias.

Frequently Asked Questions

What is the Transglide Expandable Introducer used for?

It is used to facilitate the insertion of embolization coils and other devices requiring vascular access.

What specialties typically use this device?

Interventional cardiologists and radiologists commonly use this device.

What are the FDA-cleared indications?

It is indicated for procedures requiring the introduction of embolization coils into the vascular system.

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.

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