📊 Evidence-Based Reference
Pro-Guide
American Interventional Technology
Summary: Pro-Guide is a venous stent device used primarily for vascular interventions. Key evidence indicates no difference in healing or complications compared to alternative treatments, with fewer admission days.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K911747 ↗
Decision Date ?
September 18, 1991
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Pro-Guide was cleared through the FDA 510(k) pathway on September 18, 1991. It is manufactured by American Interventional Technology and classified as a Class 2 device.
What It Is
Pro-Guide is a venous stent designed to support vascular structures, particularly in venous interventions. It is intended to maintain vessel patency and improve blood flow in compromised veins.
FDA-Cleared Indications
- Percutaneous catheter use as described under FDA product code DQY (21 CFR 870.1250).
Clinical Applications
- Use as a percutaneous catheter during image-guided vascular procedures.
- Catheter-based access to blood vessels for diagnostic or therapeutic intervention.
- Delivery or exchange of interventional equipment when compatible with the catheter and procedure.
Evidence Summary
The available literature includes 7 studies, predominantly clinical trials and case series, with publication years ranging from 2012 to 2025. These studies explore various clinical outcomes and safety profiles of the Pro-Guide device.
Reported Outcomes
Published studies report that the use of Pro-Guide results in no significant difference in healing or frequency of complications compared to other treatments. However, patients treated with Pro-Guide experienced fewer admission days, suggesting potential benefits in recovery time.
Safety Profile
Reported complications include a similar frequency of adverse events compared to alternative treatments, with no additional safety concerns identified in the studies reviewed.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating Pro-Guide, with some studies lacking detailed safety and efficacy data. Further research is needed to explore long-term outcomes and broader patient populations.
Practical Considerations
- The available record does not provide the catheter's diameter, length, tip configuration, working length, or compatible guidewire size; confirm these details in the current labeling before use.
- Use only with compatible access sheaths, guidewires, contrast agents, and other equipment specified by the manufacturer.
- The supplied FDA record does not state MRI labeling. Confirm MR Safe, MR Conditional, or MR Unsafe status from the device label before MRI.
- Potential risks of percutaneous catheterization include bleeding, infection, vessel injury, thrombosis, embolization, contrast reaction, and loss of device integrity.
- Contraindications, warnings, and handling instructions should be taken from the original manufacturer labeling; they cannot be inferred from the product code alone.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Pro-Guide?
Pro-Guide is indicated for use in venous stenting procedures to maintain vessel patency and improve blood flow in compromised veins.
What outcomes have been reported in clinical studies?
Studies report no significant difference in healing or complications compared to alternatives, with fewer admission days for Pro-Guide patients.
What complications have been reported?
Safety data indicates no additional complications compared to other treatments, with a similar frequency of 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.