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terumo support catheter
Terumo Medical
Summary: The Terumo Support Catheter is a Class 2 medical device used primarily in venous stenting procedures. It was FDA-cleared via the 510k pathway in 2011. Key evidence highlights its role in managing chronic venous insufficiency.
FDA Clearance Information
Pathway
510K
Number
K110540 ↗
Decision Date
May 13, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Terumo Support Catheter was cleared by the FDA through the 510k pathway on May 13, 2011. It is manufactured by Terumo Medical and classified as a Class 2 device.
What It Is
The Terumo Support Catheter is designed to assist in the delivery of stents and other devices during venous interventions. It is used to provide support and facilitate the navigation of complex vascular pathways.
Clinical Applications
Commonly used in procedures involving venous stenting, the Terumo Support Catheter is instrumental in treating conditions like chronic venous insufficiency and varicose veins, particularly in patients with venous obstruction or reflux.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series. These studies span from 2023 to 2025, focusing on the device's efficacy and safety in venous interventions.
Reported Outcomes
Published studies report that the Terumo Support Catheter is effective in managing chronic venous insufficiency and facilitating venous stenting procedures. Outcomes indicate improved vascular access and reduced procedural complications in venous interventions.
Safety Profile
Reported complications include minor procedural risks such as vascular injury and thrombosis. However, the overall safety profile is favorable, with low incidence of severe adverse events in the reviewed studies.
Evidence Limitations
Current evidence is limited by the variability in study designs and patient populations. Further research is needed to establish long-term outcomes and to compare the device's efficacy with alternative interventions.
Frequently Asked Questions
What are the clinical indications for Terumo Support Catheter?
The Terumo Support Catheter is indicated for use in venous stenting procedures, particularly in patients with chronic venous insufficiency and related conditions.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved vascular access and reduced procedural complications in venous interventions using the Terumo Support Catheter.
What complications have been reported?
Safety data from evidence indicate minor procedural risks such as vascular injury and thrombosis, with a low incidence of severe adverse events.
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.