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total across
Medtronic Vascular
Summary: Total Across is a venous stent manufactured by Medtronic Vascular, primarily used for treating venous obstructions. Key evidence includes 15 studies examining its efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K133539 ↗
Decision Date
March 26, 2014
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Total Across device was cleared by the FDA via the 510k pathway on March 26, 2014. It is manufactured by Medtronic Vascular and classified as a Class 2 device.
What It Is
Total Across is a venous stent designed to treat venous obstructions by providing structural support to the vein. It is intended for use in patients with conditions that lead to venous insufficiency.
Clinical Applications
Common clinical scenarios for using Total Across include treating patients with chronic venous insufficiency and venous obstructions. It is often used in cases where non-invasive treatments have failed.
Evidence Summary
The available literature includes 15 studies, encompassing various study types such as RCTs and retrospective analyses. These studies were published between 2022 and 2025.
Reported Outcomes
Published studies report mixed outcomes regarding the efficacy of Total Across in improving venous flow and reducing symptoms of venous insufficiency. However, specific efficacy data from the provided studies is limited.
Safety Profile
Reported complications include typical risks associated with venous stenting, such as stent migration and thrombosis. However, specific safety data from the provided studies is not detailed.
Evidence Limitations
The evidence base for Total Across is limited by a lack of detailed outcome and safety data in the provided studies. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for Total Across?
Total Across is indicated for the treatment of venous obstructions and chronic venous insufficiency.
What outcomes have been reported in clinical studies?
The studies report mixed outcomes on efficacy, but specific findings are not detailed in the provided evidence.
What complications have been reported?
Reported complications include stent migration and thrombosis, though specific safety data is limited.
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.