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glidesheath slender
Terumo Medical
Summary: The Glidesheath Slender is a thin-walled introducer sheath used primarily for transradial access in coronary and neurointerventions. Key evidence highlights its potential to reduce radial artery occlusion compared to conventional sheaths.
FDA Clearance Information
Pathway
510K
Number
K142183 ↗
Decision Date
November 21, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Glidesheath Slender was cleared by the FDA via the 510k pathway on November 21, 2014. It is manufactured by Terumo Medical and is classified as a Class 2 device.
What It Is
The Glidesheath Slender is a vascular introducer sheath designed with a thinner outer wall to facilitate transradial access. It is intended for use in coronary angiography and interventions, as well as neurointerventions, where minimizing access site complications is critical.
Clinical Applications
Commonly used in coronary angiography and percutaneous coronary interventions, the Glidesheath Slender is also employed in neurointerventions requiring transradial access. Its design aims to reduce complications associated with radial artery access.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, retrospective analyses, and case series, published between 2023 and 2024. These studies evaluate the efficacy and safety of the Glidesheath Slender in various clinical settings.
Reported Outcomes
Published studies report that the Glidesheath Slender may reduce the incidence of distal radial artery occlusion compared to conventional sheaths. It has been associated with high procedural success rates in transradial neurointerventions. The device's thin-walled design is noted for potentially improving patient comfort and reducing bleeding complications.
Safety Profile
Reported complications include radial artery spasm and occlusion, although the Glidesheath Slender's design aims to mitigate these issues. Some studies highlight a low rate of access site complications when using this device in neurointerventions.
Evidence Limitations
Current evidence is limited by the lack of large-scale, multicenter randomized trials. Further research is needed to confirm long-term outcomes and to explore the device's efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Glidesheath Slender?
The Glidesheath Slender is indicated for use in coronary angiography, percutaneous coronary interventions, and neurointerventions requiring transradial access.
What outcomes have been reported in clinical studies?
Studies have reported reduced incidence of distal radial artery occlusion and high procedural success rates in neurointerventions with the Glidesheath Slender.
What complications have been reported?
Safety data indicate potential complications such as radial artery spasm and occlusion, though these are reportedly minimized with the Glidesheath Slender.
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.