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guidion
Imds Operations
Summary: Guidion is a venous stent used in vascular interventions, primarily for complex chronic total occlusions (CTOs). Key evidence highlights its use in retrograde recanalization procedures.
FDA Clearance Information
Pathway
510K
Number
K210110 ↗
Decision Date
March 31, 2021
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The guidion device was cleared via the FDA 510(k) pathway on March 31, 2021. Manufactured by Imds Operations, it is classified as a Class 2 device under product code DQY.
What It Is
Guidion is a venous stent designed for use in vascular interventions, particularly in the recanalization of complex chronic total occlusions. It facilitates the retrograde advancement of microcatheters through challenging vascular pathways.
Clinical Applications
Guidion is commonly used in procedures involving retrograde recanalization of chronic total occlusions, especially when traditional access is difficult. It is particularly useful in cases requiring precise navigation through septal or epicardial connectors.
Evidence Summary
The available literature includes three studies, with one focusing on the use of guidion in retrograde recanalization of CTOs. The studies range from 1973 to 2017, encompassing various study types.
Reported Outcomes
Published studies report that guidion is effective in facilitating the retrograde recanalization of complex CTOs. The device aids in the advancement of microcatheters, improving procedural success rates in challenging cases.
Safety Profile
Reported complications include challenges in advancing microcatheters through septal/epicardial connectors. No specific adverse events were detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of recent comprehensive trials. Further research is needed to evaluate long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for guidion?
Guidion is indicated for use in the recanalization of complex chronic total occlusions, particularly in retrograde procedures.
What outcomes have been reported in clinical studies?
Studies report improved success rates in retrograde recanalization of CTOs using guidion, facilitating microcatheter advancement.
What complications have been reported?
Reported complications include difficulties in advancing microcatheters through certain vascular pathways, though specific adverse events were not detailed.
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.