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glidesheath
Terumo Medical
Summary: The Glidesheath, manufactured by Terumo Medical, is a sheath used primarily in transradial access for coronary and neurointerventions. Key evidence suggests its use may reduce radial artery occlusion compared to conventional sheaths.
FDA Clearance Information
Pathway
510K
Number
K082644 ↗
Decision Date
September 18, 2008
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Glidesheath was cleared by the FDA through the 510(k) pathway on September 18, 2008. It is manufactured by Terumo Medical and classified as a Class 2 device.
What It Is
The Glidesheath is a vascular access sheath designed for use in transradial procedures. It features a thinner wall compared to conventional sheaths, which facilitates easier insertion and potentially reduces vascular complications.
Clinical Applications
The Glidesheath is commonly used in coronary angiography and percutaneous coronary interventions via transradial access. It is also utilized in neurointerventions where smaller diameter sheaths are preferred.
Evidence Summary
The available literature includes 15 studies, primarily randomized controlled trials and retrospective analyses, conducted between 2023 and 2024. These studies focus on the device's impact on radial artery occlusion and procedural 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 spasm and occlusion, although the Glidesheath's design aims to mitigate these issues. The use of subcutaneous nitrate administration alongside the Glidesheath has been explored to further reduce complications.
Evidence Limitations
Current evidence is limited by the small sample sizes and the short duration of follow-up in some studies. Further research is needed to establish long-term outcomes and to compare the Glidesheath with other sheath technologies in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Glidesheath?
The Glidesheath is indicated for use in transradial access during coronary angiography and percutaneous coronary interventions.
What outcomes have been reported in clinical studies?
Studies have reported a reduction in distal radial artery occlusion and lower risks of major bleeding with the use of the Glidesheath.
What complications have been reported?
Reported complications include radial artery spasm and occlusion, though these are less frequent with the Glidesheath compared to conventional sheaths.
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.