📊 Evidence-Based Reference
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 ?
510(k)
Number ?
K133539 ↗
Decision Date ?
March 26, 2014
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- The FDA record classifies the device under product code DQY: Catheter, Percutaneous, 21 CFR 870.1250.
- The available record does not include a device-specific FDA indications-for-use statement beyond its classification as a percutaneous catheter.
Clinical Applications
- Use as a percutaneous catheter during an intravascular procedure when consistent with the device's cleared labeling.
- Use with compatible catheter-based equipment according to the manufacturer's instructions for use.
Reported off-label uses
- Venous stenting for iliac or central venous obstruction has been described for venous stent devices, but the available FDA record does not establish that this specific product is cleared for that use.
- Use during catheter-based treatment of chronic venous obstruction or insufficiency should be considered off-label unless supported by the product's complete labeling.
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 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.
Practical Considerations
- Confirm the exact device model, intended anatomy, dimensions, delivery system and compatibility requirements in the current manufacturer's instructions for use before use.
- Do not infer stent dimensions, vessel compatibility or deployment characteristics from the DQY product code alone.
- Review contraindications, warnings, required guidewires and other accessory-device compatibility in the complete labeling.
- MRI safety or conditional status is not established by the information provided; verify the specific model's MRI labeling before scanning.
- The FDA clearance date was March 26, 2014, but clearance does not by itself establish a recommended dwell time or clinical durability.
Procedures that use this device
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.