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modification to glidesheath
Terumo Medical
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
510K
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.
Clinical Applications
This device is commonly used in procedures requiring vascular access, particularly in transradial coronary angiography. It is designed to enhance procedural efficiency and patient safety by reducing the risk of arterial occlusion.
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.
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.