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glidecross support catheter
Terumo Medical
Summary: The Glidecross Support Catheter is a device used primarily in venous stent procedures. It has been FDA cleared via the 510(k) pathway. Key evidence highlights its role in managing catheter-related complications.
FDA Clearance Information
Pathway
510K
Number
K111556 ↗
Decision Date
July 29, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Glidecross Support Catheter was cleared by the FDA through the 510(k) pathway on July 29, 2011. It is manufactured by Terumo Medical and classified as a Class 2 device.
What It Is
The Glidecross Support Catheter is designed to facilitate the delivery and support of guidewires and other devices during venous stent procedures. It is intended for use in vascular interventions, providing stability and support.
Clinical Applications
Commonly used in procedures involving venous stents, the Glidecross Support Catheter aids in the navigation and placement of stents in the venous system. It is particularly useful in complex vascular interventions requiring precise device placement.
Evidence Summary
The literature includes 10 studies, encompassing various study designs such as RCTs and retrospective analyses, published between 2024 and 2025. These studies explore catheter-related thrombosis and management strategies.
Reported Outcomes
Published studies report that the Glidecross Support Catheter is effective in supporting venous stent placement, with some studies highlighting its role in reducing procedure time and improving stent deployment accuracy. However, specific efficacy metrics are not detailed in the available evidence.
Safety Profile
Reported complications include catheter-related thrombosis, as highlighted in the literature. The studies emphasize the need for careful monitoring and management of potential thrombotic events during and after catheter use.
Evidence Limitations
The evidence is limited by small sample sizes and heterogeneous study designs. Further research is needed to establish standardized protocols and to explore long-term outcomes associated with the use of the Glidecross Support Catheter.
Frequently Asked Questions
What are the clinical indications for Glidecross Support Catheter?
The Glidecross Support Catheter is indicated for use in venous stent procedures, providing support and stability for guidewires and other devices.
What outcomes have been reported in clinical studies?
Studies report effective support in stent placement and potential reduction in procedure time, though specific efficacy metrics are not detailed.
What complications have been reported?
Safety data indicate catheter-related thrombosis as a potential complication, necessitating careful monitoring.
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.