đź“Š Evidence-Based Reference
glidesheath slender
Terumo Medical
Summary: The Glidesheath Slender is a thin-walled vascular access sheath designed for coronary procedures via the radial artery. Key evidence suggests its potential to reduce radial artery complications compared to conventional sheaths.
FDA Clearance Information
Pathway
510K
Number
K173831 ↗
Decision Date
May 8, 2018
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Glidesheath Slender was cleared by the FDA through the 510(k) pathway on May 8, 2018. It is manufactured by Terumo Medical and classified as a Class 2 device.
What It Is
The Glidesheath Slender is a vascular access sheath with a thinner outer wall, designed to facilitate coronary angiography and interventions via the radial artery. Its design aims to minimize vascular trauma and reduce the risk of complications.
Clinical Applications
Commonly used in coronary angiography and percutaneous coronary interventions, the Glidesheath Slender is particularly beneficial in patients with smaller radial arteries, where minimizing vascular trauma is crucial.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials and retrospective analyses, conducted between 2022 and 2024. These studies explore the device's efficacy and safety in reducing radial artery complications.
Reported Outcomes
Published studies report that the Glidesheath Slender may reduce the incidence of distal radial artery occlusion compared to conventional sheaths. It is also associated with fewer radial artery complications when used with subcutaneous nitrate administration.
Safety Profile
Reported complications include radial artery spasm and occlusion, although the Glidesheath Slender's design aims to mitigate these issues. No significant adverse events have been consistently reported across studies.
Evidence Limitations
Current evidence is limited by the small sample sizes and the lack of long-term follow-up data. Further research is needed to confirm the device's benefits and safety profile in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Glidesheath Slender?
The Glidesheath Slender is indicated for use in coronary angiography and percutaneous coronary interventions via the radial artery.
What outcomes have been reported in clinical studies?
Studies have reported a reduction in distal radial artery occlusion and fewer complications compared to conventional sheaths.
What complications have been reported?
Safety data indicate potential complications such as radial artery spasm and occlusion, though these are less frequent 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.