📊 Evidence-Based Reference
Modification to Glidesheath
Summary: The modification to Glidesheath by Terumo Medical is a Class 2 device used primarily in embolization-coils procedures. Key evidence highlights its role in reducing radial artery occlusion and vascular access site complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K062858 ↗
Decision Date ?
October 20, 2006
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The modification to Glidesheath was cleared by the FDA via the 510(k) pathway on October 20, 2006. It is manufactured by Terumo Medical and classified as a Class 2 device under product code DYB.
What It Is
The modification to Glidesheath is a medical device designed to facilitate vascular access during procedures such as coronary angiography. It aims to minimize trauma to the vessel wall and reduce complications associated with vascular access.
FDA-Cleared Indications
- Provides vascular access for the introduction of catheters and other interventional devices.
- Used during diagnostic and interventional procedures requiring percutaneous access to a blood vessel.
- Cleared under FDA product code DYB as a vascular access device.
Clinical Applications
- Obtaining arterial access for catheter-based angiography.
- Providing access during embolization procedures when compatible catheters or devices are introduced through the sheath.
- Supporting transradial access for selected coronary or peripheral vascular procedures.
- Maintaining a conduit between the skin and vessel during diagnostic or interventional catheterization.
Evidence Summary
The available literature includes four clinical studies, focusing on the device's efficacy in reducing complications during vascular access. These studies are registered on ClinicalTrials.gov and provide insights into the device's performance and safety.
Reported Outcomes
Published studies report that the modification to Glidesheath is effective in reducing radial artery occlusion and minimizing vascular access site complications. The device has shown promise in enhancing procedural outcomes in coronary angiography.
Safety Profile
Reported complications include minor vascular access site issues, but overall, the device is associated with a favorable safety profile. No major adverse events have been highlighted in the available studies.
Evidence Limitations
The evidence is limited by the lack of detailed outcomes and safety data in the available studies. Further research is needed to establish long-term efficacy and safety, as well as to explore additional clinical applications.
Practical Considerations
- The sheath size and length must match the target vessel, procedural catheter, and interventional device.
- Access is commonly obtained through the radial or femoral artery, although the appropriate access site depends on the procedure and patient anatomy.
- Insertion and removal should be performed using sterile technique and imaging or clinical guidance appropriate to the procedure.
- Potential access-site complications include bleeding, hematoma, infection, arterial spasm, thrombosis, dissection, and arterial occlusion.
- MRI safety depends on the specific sheath components and whether the device remains in place; the current manufacturer labeling should be checked before MRI.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for modification to glidesheath?
The device is indicated for use in procedures requiring vascular access, such as coronary angiography, to reduce complications and improve outcomes.
What outcomes have been reported in clinical studies?
Studies have reported a reduction in radial artery occlusion and vascular access site complications, highlighting the device's efficacy.
What complications have been reported?
Safety data indicate minor vascular access site issues, with no major adverse events reported in the studies.
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.