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trisalus triguidetm guiding catheter
Trisalus Life Sciences
Summary: The Trisalus TriGuideTM Guiding Catheter is a device designed for use in venous stent procedures. It is primarily used in interventional radiology for managing venous thromboembolism. Key evidence highlights its role in cancer-associated VTE management.
FDA Clearance Information
Pathway
510K
Number
K233858 ↗
Decision Date
December 27, 2023
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Trisalus TriGuideTM Guiding Catheter was cleared by the FDA through the 510(k) pathway on December 27, 2023. It is manufactured by Trisalus Life Sciences and classified as a Class 2 medical device.
What It Is
The Trisalus TriGuideTM Guiding Catheter is a medical device used in interventional radiology to facilitate the placement of venous stents. It is designed to guide and support the delivery of therapeutic agents or devices within the venous system.
Clinical Applications
Commonly used in the management of venous thromboembolism, particularly in cancer patients, the device aids in procedures such as catheter-directed thrombolysis and stent placement. It is integral in interventional oncology settings.
Evidence Summary
The available literature includes three studies, comprising retrospective and prospective designs, published between 2021 and 2025. These studies explore the device's application in venous thromboembolism management and interventional oncology.
Reported Outcomes
Published studies report that the Trisalus TriGuideTM Guiding Catheter is effective in facilitating interventional procedures for venous thromboembolism, particularly in cancer patients. The device has shown utility in improving procedural outcomes in interventional oncology.
Safety Profile
Reported complications include procedural risks associated with interventional radiology techniques, such as bleeding and infection. However, specific adverse events related to the device itself are not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of studies and the retrospective nature of some research. Further prospective studies are needed to establish long-term efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for Trisalus TriGuideTM Guiding Catheter?
The device is indicated for use in venous stent procedures, particularly in the management of venous thromboembolism in cancer patients.
What outcomes have been reported in clinical studies?
Studies report effective facilitation of interventional procedures for venous thromboembolism, with improved procedural outcomes in oncology settings.
What complications have been reported?
Reported complications include general procedural risks such as bleeding and infection, with no specific adverse events directly linked to the device.
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.