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Glidesheath
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 ?
510(k)
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.
FDA-Cleared Indications
- Percutaneous introduction of intravascular devices into blood vessels.
- Provides vascular access for diagnostic and interventional procedures when used with compatible guidewires and catheters.
Clinical Applications
- Radial artery access for coronary angiography.
- Radial artery access for percutaneous coronary intervention.
- Vascular access for diagnostic angiography and catheter-based interventions.
- Access for procedures requiring introduction of compatible intravascular devices through a peripheral artery.
Reported off-label uses
- Arterial access for neurointerventional procedures, including embolization and aneurysm treatment.
- Arterial access for visceral, pelvic, and peripheral embolization procedures.
- Selected venous-access procedures when the sheath size, length, and device compatibility are appropriate.
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 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.
Practical Considerations
- Available sizes and lengths depend on the specific Glidesheath model; the sheath must match the intended guidewire, catheter, and interventional device.
- The sheath is introduced over a guidewire using standard percutaneous vascular-access technique, commonly through the radial artery but also through other suitable vessels.
- Use fluoroscopic or other appropriate imaging guidance and follow the product labeling for insertion, flushing, and removal.
- As a temporary vascular-access device, it is not intended for long-term implantation or prolonged indwelling use.
- MRI safety depends on the exact model and whether the sheath remains in place; confirm the current manufacturer labeling before MRI. Potential complications include bleeding, hematoma, arterial spasm, thrombosis, infection, dissection, and vessel occlusion.
Procedures that use this device
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.