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reverse medical microcatheter
Reverse Medical
Summary: The reverse medical microcatheter is a device used primarily in venous stenting procedures. It is FDA 510k cleared and supported by 11 studies, focusing on its application in chronic total occlusion interventions.
FDA Clearance Information
Pathway
510K
Number
K130858 ↗
Decision Date
October 11, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The reverse medical microcatheter received FDA 510k clearance on October 11, 2013. It is manufactured by Reverse Medical and classified as a Class 2 device under product code DQY.
What It Is
The reverse medical microcatheter is a specialized catheter designed for use in venous stenting procedures. It facilitates the navigation and delivery of therapeutic agents or devices within the vascular system, particularly in challenging anatomical scenarios.
Clinical Applications
This device is commonly used in procedures involving chronic total occlusions, where it aids in the retrograde approach to improve procedural success rates. It is particularly useful in cases requiring precise navigation through complex vascular pathways.
Evidence Summary
The available literature includes 11 studies, comprising various study types such as case reports and retrospective analyses, conducted between 2022 and 2024. These studies explore the device's application in complex vascular interventions.
Reported Outcomes
Published studies report that the reverse medical microcatheter significantly enhances the success rate of chronic total occlusion interventions, particularly when used in retrograde approaches. The device's design allows for improved navigation and delivery of therapeutic agents in complex vascular scenarios.
Safety Profile
Reported complications include challenges in wire externalization and crossing chronic total occlusions. However, specific adverse events directly attributed to the device were not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials and a focus on case reports and retrospective analyses. Further research is needed to establish comprehensive safety profiles and long-term outcomes.
Frequently Asked Questions
What are the clinical indications for reverse medical microcatheter?
The device is indicated for use in venous stenting procedures, particularly in chronic total occlusion interventions.
What outcomes have been reported in clinical studies?
Studies report improved success rates in chronic total occlusion procedures, especially with retrograde approaches.
What complications have been reported?
Reported complications include difficulties in wire externalization and crossing occlusions, 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.