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glidesheath
Terumo Medical
Summary: The Glidesheath by Terumo Medical is a sheath used primarily in transradial access for coronary procedures. Key evidence suggests its design may reduce radial artery occlusion compared to conventional sheaths.
FDA Clearance Information
Pathway
510K
Number
K102008 ↗
Decision Date
July 21, 2010
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Glidesheath was cleared through the FDA 510(k) pathway on July 21, 2010. 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, such as coronary angiography and percutaneous coronary intervention. It features a thin-walled design intended to minimize radial artery trauma.
Clinical Applications
Commonly used in coronary interventions, the Glidesheath facilitates access via the radial artery, offering an alternative to femoral access. It is particularly useful in procedures requiring reduced risk of bleeding and vascular complications.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials and retrospective analyses, published between 2023 and 2024. These studies investigate the efficacy and safety of the Glidesheath in reducing radial artery occlusion.
Reported Outcomes
Published studies report that the Glidesheath may reduce the incidence of distal radial artery occlusion compared to conventional sheaths. Its thin-walled design allows for the use of larger catheters without increasing the risk of vascular complications.
Safety Profile
Reported complications include radial artery occlusion and spasm, though the Glidesheath's design aims to mitigate these risks. No major adverse events were highlighted in the available studies.
Evidence Limitations
The evidence is limited by the small number of randomized controlled trials and the short follow-up periods. Further research is needed to confirm long-term safety and efficacy outcomes.
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 radial artery occlusion rates with the use of the Glidesheath compared to conventional sheaths.
What complications have been reported?
Safety data indicate potential complications such as radial artery occlusion and spasm, although these are less frequent with the Glidesheath.
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.