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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
510K
Number
K911747 ↗
Decision Date
September 18, 1991
Product Code
DQY
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.
Clinical Applications
Pro-Guide is commonly used in clinical scenarios involving venous insufficiency or obstruction. It is applied in procedures requiring the reinforcement of venous walls to prevent collapse and ensure adequate blood circulation.
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.
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.