📊 Evidence-Based Reference
Glidecross Support Catheter
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 ?
510(k)
Number ?
K111556 ↗
Decision Date ?
July 29, 2011
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used in percutaneous vascular procedures to provide support for the introduction and placement of guidewires and other interventional devices.
- Intended for use within the vascular system during endovascular intervention.
- FDA product code DQY identifies it as a percutaneous catheter under 21 CFR 870.1250.
Clinical Applications
- Supporting guidewire navigation during percutaneous vascular intervention.
- Facilitating delivery of compatible catheters, stents, or other endovascular devices.
- Providing catheter support during venous access and venous endovascular procedures.
- Supporting device positioning during iliac or central venous interventions when consistent with the device labeling.
Reported off-label uses
- Use as a general support catheter in peripheral arterial interventions may occur in clinical practice, but the specific application should be verified against the current manufacturer labeling.
- Use during selected complex endovascular procedures outside the labeled vascular applications may be considered by physicians based on patient anatomy and device compatibility; this is not an FDA-cleared indication.
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
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.
Practical Considerations
- Select the catheter size and length based on the access route, target vessel, guidewire, and device being delivered.
- Confirm compatibility with the guidewire and any catheter, stent, or other device before use.
- Use fluoroscopic or other appropriate imaging guidance, maintain sterile technique, and avoid excessive force to reduce the risk of vessel injury or catheter damage.
- The available record does not establish that the catheter is MR Safe or MR Conditional; consult the current manufacturer instructions before MRI exposure.
- Contraindications, warnings, and adverse events should be reviewed in the current instructions for use. Potential procedural risks include bleeding, infection, thrombosis, embolization, vessel injury, and catheter fracture or entrapment.
Procedures that use this device
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.