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glidesheath
Terumo
Summary: The Glidesheath by Terumo is a vascular access device primarily used in transradial procedures. Key evidence suggests its design may reduce radial artery occlusion compared to conventional sheaths.
FDA Clearance Information
Pathway
510K
Number
K033681 ↗
Decision Date
December 11, 2003
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Glidesheath was cleared by the FDA via the 510(k) pathway on December 11, 2003. It is manufactured by Terumo and classified as a Class 2 device.
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 vessel trauma and reduce the risk of radial artery occlusion.
Clinical Applications
Commonly used in coronary interventions, the Glidesheath facilitates access through the radial artery, offering an alternative to femoral access. It is particularly useful in procedures requiring smaller diameter sheaths to minimize vascular complications.
Evidence Summary
The literature includes 15 studies, predominantly randomized controlled trials and retrospective analyses, published between 2023 and 2024. These studies explore the efficacy and safety of the Glidesheath in various clinical settings.
Reported Outcomes
Published studies report that the Glidesheath may reduce the incidence of distal radial artery occlusion compared to conventional sheaths. It is associated with lower risks of major bleeding and vascular complications in transradial access procedures.
Safety Profile
Reported complications include radial artery occlusion and spasm, which are common in transradial procedures. However, the Glidesheath's design aims to mitigate these risks by reducing vessel trauma.
Evidence Limitations
Current evidence is limited by the small number of randomized controlled trials and the need for larger, multicenter studies to confirm findings. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Glidesheath?
The Glidesheath is indicated for use in transradial procedures such as coronary angiography and percutaneous coronary intervention.
What outcomes have been reported in clinical studies?
Studies report reduced incidence of radial artery occlusion and lower risks of major bleeding compared to conventional sheaths.
What complications have been reported?
Safety data indicate potential complications such as radial artery occlusion and spasm, although the device 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.