Glidesheath
FDA Clearance Information
The Glidesheath was cleared by the FDA via the 510(k) pathway on December 1, 2015. It is manufactured by Terumo Medical and is classified as a Class 2 device under product code DYB.
What It Is
FDA-Cleared Indications
- Used to introduce and guide catheters and other intravascular devices during diagnostic or interventional procedures.
- Intended for percutaneous access to blood vessels when vascular access is required for an endovascular procedure.
Clinical Applications
- Radial artery access for coronary angiography.
- Radial artery access for percutaneous coronary intervention.
- Percutaneous vascular access for diagnostic angiography and other catheter-based interventions.
- Access for selected endovascular procedures requiring a small-profile vascular sheath.
Reported off-label uses
- Transradial neurointerventional procedures, such as cerebral angiography and selected embolization procedures.
- Transradial or transulnar access for peripheral angiography and embolization procedures.
- Small-profile access for selected visceral, pelvic, or genitourinary 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
Reported Outcomes
Safety Profile
Evidence Limitations
Practical Considerations
- Available sizes and lengths vary by model; the sheath must match the intended catheter or device diameter and the target vessel.
- Use fluoroscopic or other appropriate imaging guidance and follow standard sterile vascular-access technique.
- Radial access requires assessment of vessel size, circulation, and the risk of radial artery spasm or occlusion.
- MRI safety depends on the specific product configuration and whether the sheath remains in place; consult the current manufacturer labeling before MRI.
- Potential complications include bleeding, hematoma, infection, vessel injury, arterial spasm, thrombosis, and radial artery 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 procedures, such as coronary angiography and percutaneous coronary intervention, where reducing radial artery complications is desired.
What outcomes have been reported in clinical studies?
Studies have reported that the Glidesheath may reduce the incidence of distal radial artery occlusion and is associated with lower risks of bleeding and vascular complications.
What complications have been reported?
Reported complications include radial artery occlusion and spasm, particularly when using large-bore catheters, although the Glidesheath's design aims to reduce these risks.