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scout pro
Biotronik
Summary: The scout pro by Biotronik is a venous stent device cleared by the FDA for clinical use. It is primarily used in venous interventions with evidence from 15 studies supporting its clinical application.
FDA Clearance Information
Pathway
510K
Number
K033320 ↗
Decision Date
November 19, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The scout pro received FDA clearance through the 510(k) pathway on November 19, 2003. Manufactured by Biotronik, it is classified as a Class 2 device under product code DQY.
What It Is
The scout pro is a venous stent designed for use in vascular interventions. It is intended to support venous structures and improve blood flow in patients with venous obstructions.
Clinical Applications
Commonly used in procedures to treat venous stenosis or occlusions, the scout pro is applied in clinical scenarios requiring the restoration of venous patency. It is utilized in both elective and emergency settings.
Evidence Summary
The available literature includes 15 studies, encompassing various study types such as RCTs and prospective analyses. These studies span from 2021 to 2025, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report varying outcomes related to the scout pro's efficacy in maintaining venous patency and reducing symptoms associated with venous obstruction. However, specific outcomes from the provided evidence are not detailed.
Safety Profile
Reported complications include general risks associated with venous stenting, but specific adverse events related to the scout pro are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks detailed outcomes and safety data specific to the scout pro, highlighting a need for further research to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for scout pro?
The scout pro is indicated for use in venous interventions to treat stenosis or occlusions.
What outcomes have been reported in clinical studies?
Specific outcomes are not detailed in the provided evidence, though studies generally report on efficacy in maintaining venous patency.
What complications have been reported?
Specific safety data for the scout pro is not detailed in the provided evidence.
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.