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upstream support catheter
Upstream Peripheral Technologies
Summary: The upstream support catheter is a device used in endovascular procedures, primarily for venous stenting. Key evidence highlights its role in complex femoropopliteal interventions.
FDA Clearance Information
Pathway
510K
Number
K112886 ↗
Decision Date
February 23, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The upstream support catheter was cleared by the FDA through the 510(k) pathway on February 23, 2012. It is manufactured by Upstream Peripheral Technologies and is classified as a Class 2 device.
What It Is
The upstream support catheter is designed to facilitate the delivery of interventional devices during endovascular procedures. It is intended for use in venous stenting, providing support and access to complex vascular lesions.
Clinical Applications
Commonly used in procedures involving complex femoropopliteal lesions, the upstream support catheter aids in the navigation and support of other devices during endovascular interventions. It is particularly useful in challenging vascular access scenarios.
Evidence Summary
The literature includes 12 studies, comprising randomized controlled trials and expert opinion statements, published between 2022 and 2024. These studies explore various interventional strategies and device designs.
Reported Outcomes
Published studies report that the upstream support catheter is effective in facilitating endovascular procedures, particularly in complex femoropopliteal lesions. The device has been associated with improved procedural success rates in challenging vascular interventions.
Safety Profile
Reported complications include potential risks associated with catheter use, such as infection and extravasation. However, specific adverse events related to the upstream support catheter itself are not extensively detailed in the available evidence.
Evidence Limitations
The evidence is limited by a lack of large-scale, long-term studies specifically focusing on the upstream support catheter. Further research is needed to fully understand its safety profile and long-term efficacy.
Frequently Asked Questions
What are the clinical indications for the upstream support catheter?
The upstream support catheter is indicated for use in endovascular procedures, particularly for venous stenting in complex femoropopliteal lesions.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved procedural success rates in complex vascular interventions using the upstream support catheter.
What complications have been reported?
Reported complications include risks of infection and extravasation, though specific adverse events related to the catheter are not extensively detailed.
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.