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glidesheath
Terumo Medical
Summary: The Glidesheath by Terumo Medical is a vascular access device primarily used in transradial procedures. Key evidence highlights its potential to reduce radial artery occlusion compared to conventional sheaths.
FDA Clearance Information
Pathway
510K
Number
K152173 ↗
Decision Date
December 1, 2015
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Glidesheath was cleared by the FDA via the 510(k) pathway on December 1, 2015. It is manufactured by Terumo Medical and is classified as a Class 2 device under product code DYB.
What It Is
The Glidesheath is a thin-walled vascular access sheath designed for use in transradial procedures, such as coronary angiography and percutaneous coronary intervention. Its design aims to minimize vascular complications by reducing the sheath's outer diameter.
Clinical Applications
Commonly used in coronary procedures, the Glidesheath is employed in scenarios requiring transradial access, particularly where minimizing radial artery occlusion is a priority. It is also used in neurointerventions requiring smaller diameter sheaths.
Evidence Summary
The literature includes 15 studies, primarily randomized controlled trials and retrospective analyses, published between 2023 and 2024. These studies focus on the Glidesheath's efficacy in reducing radial artery complications.
Reported Outcomes
Published studies report that the Glidesheath may reduce the incidence of distal radial artery occlusion compared to conventional sheaths. It is also associated with lower risks of major bleeding and vascular complications in transradial procedures.
Safety Profile
Reported complications include radial artery occlusion and spasm, although the Glidesheath's design aims to mitigate these risks. The use of large-bore catheters may increase the likelihood of radial artery occlusion.
Evidence Limitations
The evidence is limited by a lack of large-scale, long-term studies. Most studies are single-center experiences or have small sample sizes, highlighting the need for further research to confirm findings across diverse populations.
Frequently Asked Questions
What are the clinical indications for Glidesheath?
The Glidesheath is indicated for use in transradial access procedures, such as coronary angiography and percutaneous coronary intervention, where reducing radial artery complications is desired.
What outcomes have been reported in clinical studies?
Studies have reported that the Glidesheath may reduce the incidence of distal radial artery occlusion and is associated with lower risks of bleeding and vascular complications.
What complications have been reported?
Reported complications include radial artery occlusion and spasm, particularly when using large-bore catheters, although the Glidesheath's design aims to reduce these risks.
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.