📊 Evidence-Based Reference
Glidesheath Slender
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 ?
510(k)
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.
FDA-Cleared Indications
- Introducer sheath for percutaneous access to the vascular system
- Facilitates the introduction of catheters and other intravascular devices during diagnostic and interventional procedures
- Intended for use in coronary and peripheral vascular procedures according to the applicable device labeling
Clinical Applications
- Radial artery access for coronary angiography
- Radial artery access for percutaneous coronary intervention
- Vascular access for catheter-based diagnostic procedures
- Vascular access for catheter-based interventional procedures
Reported off-label uses
- Transradial access for selected neurointerventional procedures
- Transradial access for peripheral embolization procedures
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The sheath uses a thin-wall design to provide a relatively large inner diameter with a smaller outer diameter than some conventional sheaths; available sizes and lengths should be confirmed in the current product labeling.
- Use only with guidewires, catheters, and other devices that are compatible with the sheath's inner diameter, length, and access-site requirements.
- Insertion and removal require sterile technique, appropriate imaging guidance, and assessment of arterial size, anatomy, anticoagulation, and bleeding risk.
- Potential complications include bleeding, hematoma, arterial spasm, thrombosis, infection, arterial dissection, embolization, and radial artery occlusion.
- MRI safety depends on the sheath and any associated components; it should not be assumed to be safe while in place unless the current manufacturer labeling specifically permits MRI.
Procedures that use this device
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.